LC was first performed by Mouret in France in 1987. The technique was standardized by two other French surgeons, Dubois in Paris and Perissat in Bordeaux.^4,⁵ This new technique spread very rapidly around the world; in the United States, the percentage of cholecystectomies done laparoscopically grew from zero in 1987 to almost 80% in 1992.⁶ The advent of LC also induced an estimated increase of at least 25% in the overall number of cholecystectomies performed,^7,⁸ so that the likely number of cholecystectomies performed at the present time in the United States is 800,000 per year.⁹ The number of iatrogenic injuries to the bile duct has increased accordingly.¹⁰

Many reasons may explain the increased incidence of biliary complications at the beginning of the laparoscopic era, most related to the new technical skills required to perform laparoscopically what had been done by open surgery: bidimensional vision, loss of tactile sensations, different visual approach of the hepatic pedicle, difficult hemostatic maneuvers, abuse of electrocoagulation, and lack of confidence with the new instrumentation.¹¹ The rate of injuries seemed to be related to the surgeon’s learning curve and his or her personal experience. An inversely proportional relationship between the number of cholecystectomies performed and the rate of injuries was suggested by earlier reported series.^1,¹² In a review of 77,604 LCs performed in the United States, the incidence of biliary injuries decreased from 0.6% to 0.4% (P < .001) for surgical teams having an experience of more than 100 LCs.¹ A Belgian survey¹¹ suggested the number of 50 LCs as the threshold of a completed learning curve; however, the same authors emphasized that one-third of the biliary injuries in their country had occurred with surgeons with an experience of more than 100 LCs. When reviewing several multicenter series published before 1995, totaling 198,267 LCs, the incidence of biliary injuries was 0.55% in 13 European series and 0.49% in 17 series outside Europe.¹³

In the mid-1990s, the incidence of biliary injury seemed to be three times higher for LC than for open cholecystectomy. However, these figures most likely underestimated reality because there was a tendency not to declare all the lesions, as revealed by the low rate of reply to most surveys and by the increasing number of reported lesions in direct proportion with the collected replies.¹⁴ At the present time, the incidence of biliary injuries has not substantially changed, even if a trend toward reduction has been reported by some authors.^6,¹⁵ The estimated overall incidence is 0.25% to 0.74% for major biliary lesions (Table 44.1) and 0.1% to 1.7% for minor biliary lesions (Table 44.2).¹⁶^–¹⁸ These figures are only partially explained by the still increasing number of LCs performed around the world and by the activity of young surgeons at the beginning of their learning curve. However, at least one-third of biliary injuries may be ascribed to technical mistakes during surgery.¹⁹ The learning curve is not the only risk factor of LC.

Table 44.1 Incidence of Major Biliary Lesions (Bergman’s Type B, C, and D) during Laparoscopic Cholecystectomy (LC) (Multicenter Surveys)

Table 44.2 Incidence of Minor Biliary Lesions (Bergman’s Type A) during Laparoscopic Cholecystectomy (LC) (Multicenter Surveys)

Pathogenesis

An unintentional lesion of the bile duct also may occur during an “easy” cholecystectomy performed by an experienced surgeon. Intuitively, the likelihood of injuring the bile duct should increase when the cholecystectomy is difficult and the surgeon is inexpert. Any cholecystectomy may become unexpectedly difficult during surgery; however, clinical and morphologic criteria exist that may be useful in predicting a cholecystectomy at higher risk of bile duct injury. Clinical criteria are obesity; previous abdominal surgery; cirrhosis; portal hypertension; age of the patient; and previous cholecystitis, cholangitis, or pancreatitis. Morphologic criteria revealed by preoperative abdominal ultrasound are related to the gallbladder status (scleroatrophic gallbladder, thickening of the gallbladder wall, gallbladder distention resulting from a stone in the infundibulum) and to the liver (hepatomegaly, atrophy or hypertrophy of the liver lobes). The presence of several criteria raises the chances of being confronted with a difficult cholecystectomy and the risk of concomitant common bile duct (CBD) stones.

Unrecognized CBD stones are one of the major risk factors of cystic duct leakage after LC. The mechanism and the cause of a biliary injury remain unexplainable in at least one-third of cases.¹³ In more than 50% of cases, the injury occurs during the dissection of the cystic duct or during separation of the gallbladder neck from the CBD. Misinterpretation of the cystic duct and the CBD is the most common cause of injury.¹² Excessive traction on the gallbladder neck, especially if the tissues are not inflamed, may facilitate the injury of the CBD. Conversely, when the area is acutely or chronically inflamed or when a stone is trapped into the gallbladder infundibulum, the risk of CBD injury is higher during the dissection of the gallbladder neck from the hepatic pedicle. Other recurrent reasons for bile duct injury are related to incorrect hemostatic maneuvers in case of bleeding from the cystic artery; inappropriate use of electrocautery; and other specific maneuvers, such as intraoperative cholangiography, cystic duct dilation, and transcystic CBD instrumental exploration.

An anatomic anomaly is often reported by the surgeon as having caused a biliary injury. Variations of the biliary anatomy, especially at the level of the main hepatic confluence, are present in 50% of patients (see the section on interpretation of intrahepatic cholangiography). Surgeons must be aware of such variations and must keep in mind the danger of injuring aberrant ducts originating in the right liver during dissection of the gallbladder pedicle. Aberrant ducts must not be interpreted as accessory ducts because the biliary distribution within the liver parenchyma is of a terminal type; this implies that there are no intrahepatic anastomoses between the ducts and that every injury of an aberrant duct would determine functional exclusion of the corresponding liver area. Injury to a small aberrant duct may still be considered a minor lesion; however, it would cause a bile leak into the peritoneal space with all the related consequences. Another cause of injury is clipping or ligation of an aberrant duct. This injury does not involve a bile leak but entails the functional exclusion of the corresponding liver area leading to its progressive atrophy and hypertrophy of the remaining liver parenchyma. This possible event may be clinically totally asymptomatic and noted only by an increase in biochemical parameters of cholestasis and cytolysis (Fig. 44.1). Although there is no indication of treatment in asymptomatic cases, if the obstructed ducts become infected, recurrent cholangitis is the typical clinical manifestation often requiring operative reestablishment of an adequate bile flow.

Fig. 44.1 This patient presented 2 years after laparoscopic cholecystectomy (LC) with only occasional minor right upper quadrant pain and slightly elevated liver function tests. A, Magnetic resonance cholangiography shows complete obstruction and dilation of the right biliary ductal system with normal common bile duct (CBD) and left biliary ductal system. B, Abdominal magnetic resonance imaging shows hypotrophy of the right liver and compensatory hypertrophy of the left liver.

Clinical Features

Schematically, three main clinical pictures are characteristic of a bile duct injury: (1) external biliary fistula, (2) choleperitoneum, and (3) obstructive jaundice with or without the features of acute cholangitis. Various combinations of these clinical pictures may also be present. Most importantly, although some of the clinical manifestations, such as uncomplicated jaundice or well-drained external bile leakage, do not require any emergency treatment, the presence of infection must be regarded as an important criterion that requires intensive care and rapid decisions to treat sepsis. Septic complications are the main reason for mortality in these patients in the postoperative period. External biliary fistula and choleperitoneum are both typical features of the immediate postoperative period, whereas obstructive jaundice may occur either immediately after surgery or later, within days to several years. When symptoms arise late after surgery because of a slow progression from injury to stricture, overt jaundice may be absent, and the clinical picture is typically that of anicteric cholestasis, with or without itching, and recurrent bouts of acute cholangitis.

The suspicion of bile duct injury is not always straightforward. When subtle symptoms such as abdominal dull pain, abdominal distention, low-grade fever, and nausea arise in the first days after LC, one should always suspect a possible complication. Intraperitoneal bile collections may initially produce very little or no specific symptoms, but they should be quickly suspected and eventually confirmed to identify the cause and to plan the best treatment for the individual patient. Hemobilia is a rare but alarming clinical presentation of a bile duct injury. The mechanism by which a biliary injury may be associated with hemobilia is often the perforation of a pseudoaneurysm of the right hepatic artery or one of its branches into the bile ducts. These pseudoaneurysms are the result of an inadvertent intraoperative injury of the artery produced by hemostatic maneuvers during a difficult cholecystectomy. In patients with an external biliary drainage or fistula, the bleeding may become suddenly and massively apparent through the drain and may occasionally require emergency treatment.

Differential Diagnosis

Strictures occurring long after surgery may need to be distinguished from malignant strictures and other benign conditions such as primary sclerosing cholangitis. The clinical history may be helpful only in cases in which the biliary injury had been recognized and eventually treated at the time of surgery. In this setting, the stricture is usually the result of progressive scarring at the site of surgical repair. In all other circumstances, the relationship with cholecystectomy should be questioned. However, clinical presentation may be helpful in discriminating postoperative and malignant stenoses; painless jaundice is in favor of a malignant disease, whereas development of overt jaundice in benign strictures is often heralded by a long period of anicteric cholestasis and relapsing attacks of mild to severe acute cholangitis. Stricture morphology may be very helpful in discriminating scars from neoplastic involvement of the bile duct. Postoperative strictures are usually short, with sharp, often asymmetric edges, and close to the cystic duct stump. Clips may be seen lying over the bile duct or located medially to it. Biopsy or brush cytology of the stricture may add information, but these procedures are seldom required because of their low sensitivity.

Treatment

In recent years, endoscopic retrograde cholangiopancreatography (ERCP) has acquired a pivotal role in the management of postsurgical biliary complications. Both of the major typical clinical presentations occurring in this setting may be addressed by ERCP: (1) biliary leak into the peritoneal cavity or external leak and (2) obstructive syndrome with cholestasis, cholangitis, or jaundice. ERCP is indicated to confirm the clinical suspicion of biliary injury and to obtain as much morphologic information as possible. ERCP is also increasingly used as a first-line therapeutic tool in complications that are amendable to endoscopic treatment.

Endoscopic Retrograde Cholangiopancreatography and Biliary Leak

The presence of a bile leak invariably indicates a break in the continuity of the biliary system. However, the severity of the injury (ranging from simple leakage of the cystic stump to complete transection of the bile duct) and the complexity of its repair are extremely variable. The magnitude of the bile output does not usually help in presuming the origin and the size of the leak. A direct cholangiogram is of utmost importance for accurate anatomic depiction and to classify the type of injury to plan therapy. The usefulness of magnetic resonance cholangiopancreatography (MRCP) in the delineation of postoperative biliary leaks ²⁰ and of iatrogenic strictures²¹ has been reported. However, in contrast to ERCP, MRCP has no therapeutic capability. MRCP may be recommended in anatomic situations in which the endoscopic approach is presumably difficult or occasionally impossible, such as in patients with a Billroth II anatomy and with Roux-en-Y hepaticojejunostomy.

ERCP provides a detailed morphologic picture of the biliary tree and, when indicated, offers immediate therapeutic options during the same procedure. In cases of biliary leaks, ERCP is usually required in the early postoperative period when the patient has fresh surgical scars (which are potentially painful, especially if surgery has been converted to laparotomy) and has one or more external abdominal drains placed during surgery or in the postoperative period under ultrasound or computed tomography guidance; this is why the supine position is often preferred to the usual left lateral or prone position in performing ERCP. The supine position, although a little more demanding for the operator, is also preferable for interpretation purposes, especially in the case of complex hilar lesions. The anteroposterior radiologic projection, with the liver lying on the spine, substantially helps in identifying the anatomy of the main biliary confluence and of the segmental intrahepatic ducts. Use of the supine position also allows changing the patient position obliquely in case of superimposition of the biliary branches, which may create difficulties in interpretation.

In case of external biliary fistula through an abdominal drain, it is not advisable to start the procedure by injecting contrast medium through the drain (fistulography). In most instances, especially in minor lesions, the contrast medium freely flows into the peritoneal space without depicting the biliary tree. The presence of contrast medium overlapping the area involved by the lesion may hinder the correct interpretation of subsequent cholangiography and occasionally disguise the picture entirely. In contrast, fistulography is indicated whenever endoscopic cholangiography shows an incomplete filling of the biliary system resulting from a complete transection of the main bile duct or lack of visualization of a sectorial or segmental intrahepatic branch. As an alternative to contrast medium, which occasionally might not fill the missing branch, air may be used to obtain a pneumocholangiogram.²²

The technique of ERCP in the setting of a suspected biliary injury does not substantially differ from the routine examination. Special attention should be paid to the injection of contrast medium, however, which should be slow and careful to allow precise delineation of the lesions. Massive injection of the biliary tree should be avoided. Minimal injection and early filling x-ray films are also important in detecting small residual CBD stones, which are present in 20% of patients with biliary leakage originating from the cystic duct stump. If the suspected lesion is located in an intrahepatic biliary branch, it is of paramount importance to obtain a complete intrahepatic cholangiogram; to achieve an adequate pressure of injection, especially if a sphincterotomy has been previously performed, the use of an occlusion balloon catheter is advisable. Intrahepatic biliary anatomy is better shown by multiple x-ray films taken in different projections. Percutaneous transhepatic cholangiography and MRCP should be reserved for patients in whom ERCP fails technically or fails to show the intrahepatic biliary anatomy because of proximal ductal disruption.²³

Interpretation of Intrahepatic Cholangiography

The main biliary confluence is formed by the union of the right and left hepatic ducts that drain the bile originating in the right hemiliver and the left hemiliver. The main confluence is often incorrectly called bifurcation in the English literature; actually, although the portal vein and the hepatic artery carrying the blood to the liver have bifurcations, the fusion of ducts collecting the bile from the liver with a flow directed toward the CBD generates a confluence. According to the segmental liver anatomy described by Couinaud,²⁴ the left hepatic duct collects the bile originating from segments II and III (left anatomic liver lobe or left lateral sector) and from segment IV (quadrate lobe). One or more small ducts originating from segment I (caudate lobe) also join the left hepatic duct close to the main confluence. The anatomic variations occurring in the left hepatic system are rare and are irrelevant in this perspective. The right hepatic duct is shorter than the left hepatic duct and follows the same axis of the common hepatic duct. The right hepatic duct originates from the confluence of the right anteromedial sectorial duct (segments V and VIII) and of the right posterolateral sectorial duct (segments VI and VII). The right anteromedial duct is recognizable thanks to its orientation, which follows the same axis of the right hepatic duct, whereas the right posterolateral duct joins the right anteromedial duct on its medial aspect with a typical umbrella handle–like shape.

This normal anatomy (called “modal” by Couinaud) is present in approximately 60% of the population (Fig. 44.2). The main hepatic confluence is usually located high in the hilar region. A lower position at the level of the hepatic pedicle may also occur, causing a much closer proximity to the insertion of the cystic duct into the hepatic duct (Fig. 44.3). The main variations of the main hepatic confluence are the absence of the right hepatic duct with the anteromedial and posterolateral right ducts joining independently the left duct to form the confluence (Fig. 44.4) or with one of the two right sectorial ducts joining the CBD at a more distal level closer to the insertion of the cystic duct (Fig. 44.5). More rarely, an isolated segmental or subsegmental duct may join the CBD away from the main confluence, usually on the lateral aspect of the CBD close to the insertion of the cystic duct. Most aberrant ducts arise from the right liver and drain into the common hepatic duct or cystic duct within 30 mm of the hepatocystic angle.²⁵

Fig. 44.2 A and B, Normal distribution of intrahepatic bile ducts: common hepatic duct (light green), left hepatic ducts (blue), right hepatic duct (dark green), right anteromedial duct (red), and right posterolateral duct (yellow).

Fig. 44.3 Endoscopic retrograde cholangiopancreatography (ERCP) shows low main confluence with the cystic duct joining the right hepatic duct on its medial aspect.

Fig. 44.4 A and B, Absence of the right hepatic duct. Light green, common hepatic duct; blue, left hepatic ducts; red, right anteromedial duct; yellow, right posterolateral duct.

Fig. 44.5 A and B, Absence of the right hepatic duct. On endoscopic retrograde cholangiopancreatography (ERCP), the cystic duct joins the right anteromedial duct on its lateral aspect. Light green, common hepatic duct; blue, left hepatic ducts; red, right anteromedial duct; yellow, right posterolateral duct.

These are the most dangerous anatomic variations for the surgeon during the dissection of the gallbladder pedicle. Apart from complete transection of the CBD (type D of the Bergman classification) (Fig. 44.6), which is typically an indication for open surgical repair, an attempt at endoscopic treatment may be envisaged in all other circumstances of biliary injury with concomitant bile leak. The basic principle of endoscopic treatment is abolition of the transpapillary pressure gradient, equalizing the bile duct and duodenal pressures and allowing flow of bile into the duodenum.²⁶

Fig. 44.6 Endoscopic retrograde cholangiopancreatography (ERCP) shows complete transection of the common bile duct (CBD) with contrast medium freely flowing into the subhepatic peritoneal space.

Endoscopic Treatment of Minor Lesions

The largest part of biliary leaks from minor lesions originates from the cystic duct stump (Fig. 44.7). Bile leakage from the cystic duct stump may be due to stump dehiscence resulting from defective technique in clips positioning, inadvertent injury to the cystic wall below the closure, or partial disruption of the cystic duct implantation into the bile duct resulting from excessive traction. Biliary hypertension resulting from temporary impaction of a residual bile duct stone into the sphincter of Oddi in the early postoperative period is most likely the cause of cystic duct stump dehiscence in almost one-fifth of patients. Similarly, a simple spasm of the sphincter of Oddi theoretically may create enough pressure to induce dislodgment of clips placed on the cystic duct stump. Bile leaks can also originate from severed ducts of Luschka (small peripheral ducts connecting the intrahepatic system with the gallbladder lumen) (Fig. 44.8), small subsegmental ducts running in the gallbladder bed, and segmental or subsegmental aberrant branches joining the CBD in the proximity of the cystic duct.

Fig. 44.7 Postoperative endoscopic retrograde cholangiopancreatography (ERCP) after laparoscopic cholecystectomy (LC), with leakage of contrast medium from the cystic duct stump.

Fig. 44.8 Postoperative endoscopic retrograde cholangiopancreatography (ERCP) after laparoscopic cholecystectomy (LC) in a case of subhepatic bile collection. The common bile duct (CBD) is normal. Two clips are visible on the cystic artery and the cystic duct. A leak of contrast medium into the gallbladder bed originates from a duct of Luschka connecting a subsegmental branch that joins the CBD lower than the main confluence.

Treatment of these leaks does not differ from treatment employed when the leak arises from the cystic duct stump (Table 44.3). The transpapillary pressure gradient can be equalized by endoscopic sphincterotomy (ES) alone,^27,²⁸ ES and stent or nasobiliary drain (NBD) placement,²⁹ and stent^30,³¹ or NBD placement alone³¹ without preliminary ES (Fig. 44.9). All methods seem to be equally effective in facilitating the closure of the biliary leak usually within 1 week of treatment.^3,^26,³⁰^–³³ The endoscopic approach of choice is controversial. However, if stones are present in the CBD, ES and stone extraction with or without stent or NBD placement seems the most logical approach. However, each option has specific limitations. ES is associated with inherent immediate and potential long-term complications; stent placement requires a second procedure to remove the stent, which can also become clogged or can migrate; and NBD requires a prolonged hospital stay, is uncomfortable for the patient, and may be accidentally displaced. Advantages and disadvantages of the different options are summarized in Table 44.4.

Table 44.3 Endoscopic Management of Biliary Leaks from Minor Lesions (Type A) after Cholecystectomy

Fig. 44.9 Postoperative endoscopic retrograde cholangiopancreatography (ERCP) after laparoscopic cholecystectomy (LC) in a case of external biliary fistula through a subhepatic drain. A, Leak of contrast medium originating in the gallbladder bed (duct of Luschka) is seen. B, Check cholangiography performed 3 days after endoscopic sphincterotomy and nasobiliary drain placement. The leakage is no longer visible.

Table 44.4 Endoscopic Options to Treat Postoperative Bile Leaks (Type A according to Bergman)

Procedure	Advantages	Disadvantages
ES	Treatment of associated CBD stones	Complications
Nasobiliary drain (days)	Avoids ES	Uncomfortable
	Allows check cholangiography	Prolongs hospitalization
Stent placement (wks)	Avoids ES	Repeat ERCP required
		Clogging, dislocation

CBD, common bile duct; ERCP, endoscopic retrograde cholangiopancreatography; ES, endoscopic sphincterotomy.

To select the optimal endoscopic therapy, Sandha and colleagues ³⁴ proposed classifying the bile leaks by ERCP into two categories: low-grade (identified only after intrahepatic opacification) and high-grade (observed before intrahepatic opacification). Of 104 low-grade leaks, 75 were treated by ES alone with a success rate of 91%. Of 100 high-grade leaks, 97 were treated by stent insertion with a final success rate (4 patients had to undergo retreatment) of 100%. The investigators concluded that this simple, practical endoscopic classification system might be clinically relevant in the choice of endoscopic therapy. Endoscopic local injection of botulinum toxin (Botox) to decrease the transpapillary bilioduodenal pressure gradient has also been reported.³⁵ Injection of 100 IU of botulinum toxin into the sphincter of Oddi was shown to lower CBD pressure significantly within 24 hours. This effect lasted for 2 weeks on average in the animal model.

Postoperative bile leaks from minor lesions (type A) are usually amendable to endoscopic management with a very high success rate. All methods seem to be equally effective in facilitating the closure of the leak within a few days.

Endoscopic Treatment of Major Lesions

Bile leakage in major lesions originates from a tear on the CBD or on one of the biliary branches that form the main hepatic confluence (type B). In both instances, ES alone may be inadequate to seal the leak. It is preferable to insert at least one large-bore plastic stent (10-Fr to 11.5-Fr) long enough to bypass the site of injury. The secondary intent of stent placement is to prevent the development of stricture at the site of the injured bile duct wall.^23,²⁶ For this purpose, the stent should be left in place for several months to allow the healing process to stabilize. In case of secondary stricture formation at the site of injury, the presence of a stent already in place facilitates successive endoscopic maneuvers to dilate the stricture. Therapeutic success may be obtained in 71% to 79% of cases (Fig. 44.10).^3,^36,³⁷

Fig. 44.10 Postoperative endoscopic retrograde cholangiopancreatography (ERCP) after laparoscopic cholecystectomy (LC) in a case of peritoneal bile collection and cholestasis. A, Stricture of the common bile duct (CBD) with clips overlapping. B, A catheter has been passed over the stricture using a guidewire; injection of contrast medium through the catheter clearly shows the site of biliary injury and the correspondent leak. C, A 10-Fr plastic stent has been placed. D, During the following months, three 10-Fr stents were inserted to dilate the stricture, one in each main biliary territory (anteromedial right, posterolateral right, and left biliary ducts). E, Balloon-occluded check cholangiography after removal of the three stents. The stricture has completely disappeared.

Biliary stents have also been successfully used to reestablish the continuity of disrupted segmental branches at the level of the main hepatic confluence ²² and for leaks from aberrant bile ducts.^23,³⁸ In major biliary injury with bile leakage, the primary therapeutic objective is to seal the leak to convert an acute problem into a stabilized condition. The high efficacy of the endoscopic approach in this setting justifies its use as a first-line treatment whenever possible. Treatment of postoperative bile duct strictures in the prelaparoscopic era was traditionally surgical. The role of ERCP was limited to the diagnostic phase and particularly to the definition of the level and extent of the lesion.³⁹

Along with the increasing use of ERCP in the evaluation and treatment of acute complications of LC, therapeutic ERCP has been increasingly employed to manage postoperative strictures occurring both early and late postoperatively. The first nonoperative alternative in the management of bile duct strictures has been the percutaneous transhepatic approach. After establishment of percutaneous access to the intrahepatic bile ducts, the stricture is crossed with a guidewire, and pneumatic balloon dilation is performed. Although instantly very effective, this approach has a very limited value in the long-term because of the high rate of stricture recurrence.⁴⁰ Approximately one-third of patients undergoing this treatment modality experience complications, and stricture recurrence develops in at least 25% of cases during follow-up.^41,⁴² In another series published by the group at The Johns Hopkins University, the success rate of these procedures was only 55%, with 20% of patients having significant hemobilia.⁴³ The high recurrence rate after percutaneous pneumatic dilation is most likely due to the forceful disruption of the scar, which can add further traumatic damage to the tissue and consequential development of new local fibrogenic reaction.

The percutaneous approach has been progressively replaced by the endoscopic approach. The endoscopic approach avoids the need for liver puncture, which is the main cause of complications of the percutaneous approach; it is not more difficult when the intrahepatic bile ducts are not dilated or only slightly enlarged, which is often the case in postoperative strictures; and it is also feasible in case of liver cirrhosis, ascites, or coagulopathy. The endoscopic approach avoids the need for long-standing percutaneous internal-external catheters, improving the patient’s comfort and compliance. At the present time, the endoscopic approach is considered the first-line nonoperative alternative to surgical treatment; in addition, it never hinders the option of a surgical approach as a rescue therapy in case of failure. Which is the best therapeutic algorithm is still debated. Both surgery and endoscopic treatment may obtain good results. However, the two alternatives have never been systematically compared in a prospective randomized trial. It is also very unlikely that such a study will ever be conducted in the future because of the relatively low incidence of this pathology, its dispersion in several centers, and the heterogeneity of its clinical and morphologic presentation, which would make it very difficult to gather cases in homogeneous groups large enough for any comparison.

Description of Technique

Endoscopic treatment of postoperative biliary strictures is based on two technical steps: (1) getting over the stricture and (2) dilation of the stricture.

Getting over the Stricture

The morphologic requirement that allows getting over the stricture is the continuity of the CBD. In case of complete transection or obstruction of the bile duct, the endoscopic option alone is applicable in only a very few cases. A combined percutaneous and endoscopic approach with an aim at reconstructing the missing segment of the bile duct has been described.⁴⁴ A similar combined approach has also been described in the case of complete obstruction of the distal biliary stump; percutaneous puncture of the distal stump was performed under radiologic guidance with a device designed for nonbiliary use (a set marketed for placing transjugular intrahepatic portosystemic shunts).⁴⁵ However, because of the lack of standardization, these approaches cannot be recommended on a routine basis.

In most cases, and especially when symptoms develop a long time after surgery, the CBD is accessible by endoscopy, and the stricture is incomplete, getting over the stricture is the preliminary step to undertake dilation. This maneuver is often much more difficult in postoperative strictures than in neoplastic strictures because the stenosis, even if commonly very short, may be asymmetric. The fibrosis makes it especially thin and tightened. It is often necessary to use thin hydrophilic guidewires (0.021 inch or 0.018 inch) with a straight or J-type extremity; their manipulation requires patience, skill, and optimal x-ray control.

The morphology of the stenosis has to be respected, and forceful maneuvers with stiff guidewires that may create false routes leading to the failure of the procedure should be strictly avoided. Changing the position of the patient may help in identifying radiologically the right pathway to follow with the guidewire. Pulling on a stone retrieval balloon inflated under the stricture may help in stretching the bile duct and in modifying the axis of the guidewire. Manipulation of bendable catheters or papillotomes may also be used to change the direction of the guidewire. When the stricture is passed, the hydrophilic guidewire is exchanged for a stiffer and more stable one to proceed to dilation.

Dilation of the Stricture

Dilation of the stricture has two objectives: (1) to reopen the bile duct to achieve a regular bile flow and (2) to secure the dilation to avoid restricture in the long-term. In the beginning of endoscopic treatment, only the first objective was pursued; in the percutaneous approach, the mainstay of treatment was pneumatic dilation alone.⁴⁶ However, it soon became clear that even if immediately very effective, pneumatic dilation alone was ineffective in granting good results in a long-term follow-up. At the present time, pneumatic dilation is mainly used as a preliminary step before placement of one or more plastic stents (Fig. 44.11). The role of stent placement is to keep the stricture open for a long time (months to years according to different treatment strategies), while allowing scar modeling and its consolidation.⁴⁷

Fig. 44.11 Postoperative stricture after laparoscopic cholecystectomy (LC) converted to open cholecystectomy. A, At the level of the main confluence, a very tight stricture has been overcome by a catheter and guidewire. B, A balloon dilator has been passed through the stricture over the guidewire. C, Balloon dilation is performed. Notice the waist on the balloon indicating high stricture firmness.

Typically, two 10-Fr stents are placed, exchanged every 3 months to avoid cholangitis resulting from stent occlusion, and left in place for 1 year. In a retrospective study from the Amsterdam group reporting on the multidisciplinary experience obtained during a decade (1981–1990), the long-term results of endoscopic treatment were compared with the long-term results of surgery.⁴⁸ Surgery (Roux-en-Y hepaticojejunostomy) was performed in 35 patients, and endoscopic treatment was performed in 66 patients. Patient characteristics, type of initial injury, and level of obstruction were not significantly different in the two groups. At a mean follow-up of 50 months and 42 months for the surgical and the endoscopic groups, 83% of patients in both groups had an excellent (asymptomatic patient with normal or stable laboratory parameters) or good (single episode of cholangitis) result. Immediate complication rate was in favor of endoscopic treatment (8% vs. 26% for surgical treatment), whereas 21% of the patients had at least one episode of cholangitis resulting from stent malfunction during the stent period (two 10-Fr stents for 1 year with stent exchange every 3 months).

When analyzing the long-term results, it becomes immediately evident how the time interval between the end of treatment and the symptomatic recurrence of the stricture is much shorter in the group with endoscopic treatment compared with the surgical group (on average 3 ± 11 months vs. 40 ± 11 months), indicating possible undertreatment in the endoscopy group. However, this important study showed that endoscopic treatment may be considered at least as effective as surgical treatment in terms of long-term results, having the big advantage of not hindering any further surgery if necessary. Several other experiences of endoscopic treatment with plastic stents of postoperative biliary strictures have been published in recent years.^3,⁴⁷^–⁵⁶ From the analysis of the available data, however, this treatment modality still seems far from standardized; the published experiences differ in terms of number of stents placed, their caliber, exchange intervals, and definition of treatment objectives and of outcomes. Examples of two different methodologic approaches follow:

The treatment protocol used by the Amsterdam group (74 patients) is the classic one, entailing placement of two 10-Fr stents, exchanged every 3 months for 1 year (the period of stent placement).⁵³ Preliminary pneumatic dilation had been performed in approximately one-fourth of the patients before stent insertion. A combined percutaneous-endoscopic approach to bypass the stricture with a guidewire was required in only three cases. Stents were removed after 1 year.

The protocol described by our group (55 patients)⁵² involved the placement of the maximum possible number of stents (ideally 10-Fr) in relation to the tightness of the stricture and diameter of the CBD at every treatment session with a trimonthly interval. Treatment was continued until complete morphologic disappearance of the stricture at cholangiography (Fig. 44.12).

Fig. 44.12 Postoperative cholangiography through a T-tube drain placed at cholecystectomy to repair complete transection of the common bile duct (CBD) at the hilum. A, Stricture and leak of contrast medium around the CBD are visible. B, At the end of the fifth treatment, 10-Fr stents have been placed. C, Balloon-occluded cholangiography after stent removal. The stricture has disappeared completely.

Preliminary balloon dilation was performed in 40% of the patients, almost always at the first treatment session. A combined percutaneous-endoscopic approach was required in three cases. The mean number of stents inserted was 1.7 (range 1 to 4) at the first session and 3.2 (range 1 to 6) at the end of the treatment. Disappearance of the stricture was checked 24 to 48 hours after removal of the stents by check cholangiography through NBD. Early complications developed in four (9%) patients (three cholangitis, one pancreatitis), and stent occlusion that required early stent exchange occurred in eight (18%) patients. Mean duration of treatment was 12.1 ± 5.3 months (range 2 to 24 months). Follow-up included clinical evaluation, laboratory parameters, and liver ultrasound every 3 months during the 1st year and every 6 months in the following years.

In the Amsterdam series, the technical success of stenting was 80%; however, only 44 patients (59% of the initial cohort and 75% of patients in whom an initial technical success had been obtained) concluded the 12-month stent period for different reasons. At a median follow-up of 9 years, 9 of 44 patients (20%) developed recurrent strictures. In eight of nine cases, recurrent strictures developed within the first 6 months of follow-up (median 2.6 months). On an intention-to-treat basis, this protocol was able to resolve definitively the bile duct stricture in 47% of the initial cohort. The results of this study suggest that endoscopic stent placement is not the best treatment option for patients with low compliance to repeated treatment sessions. Similar results, with 81% of patients symptom-free at a mean follow-up of 9.5 years, were reported in an abstract form by the Toronto group by using the same treatment protocol.⁵¹

In our study, 42 of 55 patients initially considered were evaluable at a mean follow-up of 49 months after the end of treatment. Ten patients were excluded from the protocol because of complete CBD section (n = 5) or use of self-expandable metallic stents (n = 5). Another three patients were not evaluable for different reasons. Two patients died of unrelated causes during follow-up. Among the remaining 40 patients, there was no recurrence of symptoms caused by relapsing biliary stricture. One patient sustained two episodes of cholangitis but without stricture recurrence. By an intention-to-treat analysis, the success rate was 89% (40 of 45). Although the follow-up period in our series is shorter compared with the Amsterdam series, it is longer than the typical period during which all the recurrences after endoscopic treatment have been described (2 years). This more aggressive approach to endoscopic treatment with stents seems to improve long-term results for patients with postoperative biliary strictures. We reported more recently on the very long-term results of this aggressive approach in the same cohort of patients ⁵⁷; of 35 evaluable patients after a mean follow-up of 13.7 years, 7 (20%) had recurrent cholangitis owing to relapse of the stricture in 4 patients (all successfully retreated with stents) and newly formed bile duct stones in 3 patients. The remaining 28 patients remained completely asymptomatic with normal liver function tests and abdominal ultrasound.

Despite some controversies,⁵⁸ at the present time, multiple stent placement is a well-accepted strategy adopted worldwide for postoperative bile duct strictures.^59,⁶⁰ According to the published data, endoscopic treatment with stents of major bile duct injuries and strictures is at least as effective as surgical treatment. The advantages of endoscopic treatment are its simplicity, reversibility, and minimal invasiveness. Endoscopic treatment should always be considered, whenever available, in the therapeutic algorithm of most patients with major bile duct injuries. For most patients, it may be the only treatment required. Endoscopy and surgery should be considered as complementary treatments. This complex and difficult pathology is best managed in centers in which a multidisciplinary approach is available.

Complications

Complications may occur during the first treatment session and are related to ES (acute pancreatitis, retroperitoneal perforation, and bleeding), which is usually performed to gain access to the bile ducts, or occur during the stent period. ES-related complications in this setting do not differ in frequency, severity, and management from complications encountered in other, more common situations, such as treatment of CBD stones. Complications arising during the stent period are mostly due to stent dysfunction—obstruction, migration, dislocation, and impaction. Acute cholangitis is the typical clinical manifestation of stent dysfunction. Cholangitis is usually mild and often self-limited in this setting but requires prompt endoscopic evaluation and reestablishment of correct bile drainage by stent repositioning.

A typical complication of long-term stent placement is the development of biliary sludge and stones above the stricture. This condition may cause cholangitis, but it may also be totally asymptomatic. In addition, liver function tests may be completely normal. The lack of symptoms and normal liver function tests may lead to unintentional prolongation of the planned stent period. Removal of all stones and sludge by basket or balloon extraction or both is mandatory before placement of a new stent or stents to avoid potential early reocclusion. To avoid stone formation, the trimonthly time schedule of stent replacement should not be prolonged. Patient compliance is crucial when dealing with postoperative bile duct stricture, and patients should always be fully informed of the inherent risks of not following the planned treatment program.

Future Trends

The main limitation of endoscopic treatment of postoperative bile strictures with the current method of multiple plastic stent placement is the need for repeat interventions over a long time (1 year on average). The ideal stent would allow progressive dilation of the stricture during weeks or months and would dissolve once the goal had been reached. Uncovered self-expanding metal stents (SEMS) have proved to be a bad alternative to plastic stents for several reasons.⁵⁴ First, SEMS invariably induce a hyperplastic response of the inflammatory tissue at the level of the stricture. This hyperplastic reaction ultimately leads to occlusion of SEMS, on average less than 1 year after their placement. Second, SEMS are usually not removable; treatment of secondary stricture resulting from hyperplastic reaction requires repeated balloon dilations and plastic stent placement. Third, biliary SEMS have been developed to produce abrupt recanalization of a stricture resulting from neoplastic invasion; the radial force exerted by the stent is much higher than the force desirable to induce progressive dilation of a scar, such as the scar of postoperative bile duct strictures.

Partially covered SEMS have the advantage of avoiding ingrowth of hyperplastic tissue at the level of the stricture and of being often removable ⁶¹; however, no clinical experience is available. The advent of fully covered, removable SEMS has raised new interest concerning their potential use in benign conditions.⁶² However, the experience in postoperative biliary strictures is still scanty and controversial.⁶³ Drug-eluting, self-expandable stents have been used in the vascular system to inhibit endothelial growth; it is conceivable that this technology might become available for use in the biliary system. Local release of antiinflammatory drugs able to control the fibrogenetic process that occurs during healing of a biliary injury may be valuable in this setting.

References

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