Cholecystectomy is the commonest abdominal surgery performed across the world. Cholecystectomy is a common treatment in gastrointestinal surgery, and the laparoscopic method has become the gold standard for symptomatic cholecystolithiasis and chronic and acute cholecystitis. Apart from the advantages of a much faster recovery time and better cosmetic outcome, the laparoscopic approach carries a greater risk of iatrogenic bile duct injury (IBDI) and hepatic (right) artery injury. Bile duct injury (BDI) is one of the most frightening sequelae of cholecystectomy, associated with significant perioperative morbidity and mortality, decreased long-term survival and quality of life, and a high rate of subsequent lawsuits. [1]

The reported incidence of bile duct injury following open cholecystectomy is 0.1%–0.2%. In the present era of laparoscopic cholecystectomy, the incidence has gone up to 0.4 %–0.7 % [1]. Though some of the injuries can be identified during primary surgery, the majority, however, are present in the postoperative period [2–4].

Proper identification of the injury, appropriate timing, technique of repair and experience of the surgeon are paramount in the management of these patients. Some recent studies have laid a lot of emphasis on repair by specialist hepatobiliary surgeons and considered this to be one of the most important factors in the successful outcome of BDI [5–7].

Aim

The present study is a prospective analysis of all patients with bile duct injury who were presented to us during or at a variable period after the index cholecystectomy. Their clinical presentation, management and outcome were studied.

This prospective study was done in a tertiary healthcare center in our hospital with the help of a hepatobiliary surgeon, from January 2022 to January 2025 in 118 patients. Preoperative details of all patients with hospital records for post-cholecystectomy bile duct injury were entered in our database. Patients who sustained injuries while being operated in our hospital and also who were operated elsewhere and referred to our center after the injury was detected or suspected, were included in our study. 

There are three categories of patients according to time of presentation-

Group-A injury was detected on a table during cholecystectomy

Group- B patients who presented in the early postoperative period, i.e. within 2 weeks of cholecystectomy

Group- C patients who presented 2 weeks after cholecystectomy

After receiving all the details of the patients, we classified them according to the Strasberg Classification of bile duct injury [8].

Group- A patients:

Laparoscopy was converted to open laparotomy by a wide subcostal or mid- line incision.

All the ligatures or clips barring.

Intraoperative cholangiogram was performed.

-If the common bile duct (CBD) was found to be intact, a choledochotomy was performed and an appropriate size T-tube was placed.

-Partial transection was repaired over appropriate size stent/s or T-tube using 4- 0 polygalactine (Vicryl) suture.

-In case of complete transection, an attempt was made to delineate the proximal cut end of the bile duct. hepaticojejunostomy Roux-en-Y (HJ), HJ was performed using single layer, interrupted 3-0 or 4-0 Vicryl sutures.

Trans-jejunal stent was used for very thin-walled and undilated bile duct. A wide bore tube drain was placed in the subhepatic space. The stent or T-tube was kept for 3 months and removed after obtaining satisfactory cholangiogram.

Group- B Patients:

Injury suspected on the basis of clinical background- tachycardia, jaundice, abdominal distension and bilious vomiting. Ultrasonography was performed to locate any collection, check the integrity of CBD and any distal obstruction.

-external biliary fistula without any evidence of intraabdominal sepsis- ERC or MRC [endoscopic retrograde cholangiogram, magnetic resonance cholangiogram].

Patients showing bile leakage but intact CBD were subjected to endoscopic papillotomy (EPT) and insertion of 10f plastic stent.

For patients whose ERC showed complete ‘cut-off’, the proximal biliary tree was evaluated on MRC. The MRC was analyzed for the proximal stump, the sectoral branches and any evidence of intra- abdominal collection. Early laparotomy and repair were considered if the patient was stable, did not show any signs of intra-abdominal collection or sepsis. At laparotomy, the approach to a ligated or transected CBD was similar to what has been described for group A patients.

In patients with suspected bile collections/peritonitis, an attempt was made to drain all the collection and create a controlled EBF. Localized collection drained via ultrasound guided drain and diffuse collection via re-exploration. Same sitting ERC was performed and EPT and bile duct stenting done. Large bore drains also placed in subhepatic space.

Very sick patients were managed in the intensive care unit with broad spectrum and later culture specific antibiotics. In patients with tube hepaticostomy or T-tube, the subhepatic drain was removed once it stopped draining. The T-tube was clamped if cholangiogram showed free flow of dye into duodenum. The patients were discharged home either with the tube hepaticotomy or the clamped T-tube. They were kept on regular follow-up and a definitive repair, i.e. HJ was performed at least after 3 months.

Group – C patients:

Stricture was suspected on clinical grounds and US of abdomen was performed to evaluate the biliary tree any abdominal collection. The proximal biliary tree was evaluated by MRC or fistulogram (internal/external). The internal fistulogram was performed in the radiology suite by standard end-viewing upper GI endoscope. The duodenum was intubated and the strictured hepaticoduodenostomy stoma was visualized.

The patients underwent HJ following the above-mentioned technique at least 6 weeks after the index cholecystectomy. Transjejunal stents were used selectively if the anastomosis appeared tenuous due to thin-walled, undilated ducts and local inflammation. Stents were removed 3 months later.

The follow-up protocol for these patients included clinical assessment and liver function test (LFT) every 6 months. The outcome was graded into three categories:

Grade A–no clinical symptoms, normal LFT;

Grade B–no clinical symptoms, mild derangement of LFT or occasional episodes of pain or fever;

Grade C–pain, cholangitis and abnormal LFT; grade D–surgical revision or dilatation required [9].

This prospective study done in tertiary health care centre in our hospital with help of hepatobiliary surgeon, from January 2022 to January 2025 in 118 patients. There is total 118 patients, 52 males and 66 females, mean age 50 years [range 20-62 years]. 48 patients operated for acute cholecystitis and 70 patients for chronic cholecystitis. The injury occurred open cholecystectomy in 44 patients and laparoscopic cholecystectomy in 74 patients.

Group A included 12 patients

Group B included 66 patients

Group C included 40 patients

Group A

Of the 12 patients, all had sustained injuries during laparoscopic cholecystectomy. Two patients had complete transection of the RHD (type C) and partial injury to LHD. He underwent right hepaticojejunostomy and repair of the LHD over stent. Four patients had partial transection of the common duct (type D) that was repaired over a T-tube. Six patients had complete transection of the common duct (type E2) who underwent HJ over transjejunal stent. The postoperative recovery in all the patients was uneventful, except in two who had bile leak that lasted for 2 weeks. Type A injury was diagnosed with ERC in all but only one patient in this subgroup was found to have a stone in the CBD. ERC was followed by EPT and insertion of a 10f plastic stent into the CBD. Failure of ERC in one patient was due to pre-existing pyloric stenosis. He was managed expectantly after confirming the diagnosis on MRC. Re-laparoscopy and drainage of the peritoneal cavity were performed concomitantly in patients with biliary peritonitis and bile ascites. Subhepatic bilioma was drained by US-guided percutaneously placed pigtail catheter. One patient developed mild post-ERC pancreatitis. One patient with biliary peritonitis died in the postoperative period due to fulminant sepsis and multiorgan dysfunction. Bile leaks in the remaining patients subsided in a mean period of 8 days (2 days–4 weeks).

 Group B: 

 36 patients presented with type A injury. The clinical presentation was (Table 2) controlled EBF in 26, biliary peritonitis in 6, subhepatic bilioma in

Two and bile ascites, i.e. abdominal distension without significant systemic signs in two patients. 30 patients had type E injury, which was further classified into E1–6 patients, E2–12 patients, E3–10 patients and E4–2 patient. The clinical presentation in these patients was EBF in 14, biliary peritonitis in 6, progressive jaundice in 6 and multiple intra-abdominal bile collections in 4 patients.

Type E injury was diagnosed on ERC in 12 patients and on MRC in 18 patients. Patients with biliary peritonitis (n=6) and intra-abdominal bile collection (n=4) underwent exploratory laparotomy. During laparotomy, the T- tube was inserted into the proximal and distal stumps of the CBD in 6 patients. In 4 patients, only the proximal stump could be identified and tube hepaticostomy was performed. These 4 patients underwent hepaticojejunostomy 3 months later. The patients with the T-tube underwent hepaticojejunostomy after an interval of 3 months, 6 months and 2 years, respectively. 

Group C: 

 The clinical presentation was (Table 2) cholangitis in 24, jaundice in 20, abdominal pain in 8, biliary fistula in 4 and night blindness in one patient. Eleven patients had prior intervention in the form of end-to-side hepaticoduodenostomy in four, T-tube repair in two, T-tube repair and angioembolization of right hepatic artery pseudoaneurysm in one and suture closure of bile leak in two patients. 

Cholangiographic evaluation of the proximal biliary tree was done by MRC in 17 patients, an internal fistulogram in two patients and an external fistulogram in one patient. The median interval between index cholecystectomy and definitive repair (HJ) was 8 months (range 6 weeks–10 years). One patient had postoperative bile leak and two had wound infection.

In a mean follow-up of 40 months (range 6–90 months), the outcome was grade A in 54 patients, grade B in three patients (one from each of the three groups) and grade D in one patient (group C). The latter patient with a type E3 injury developed recurrent stricture and cholangitis, necessitating percutaneous transhepatic dilatation of the stricture by the radiologist to fulminant sepsis and multiorgan dysfunction. Bile leaks in the remaining patients subsided in a mean period of 8 days (2 days–4 weeks).

Table 2 Clinical presentation in groups B and C

Table no-1 distributions of patients according to Strasberg classification

In the present era of laparoscopic cholecystectomy, it is interesting to find that a sizable proportion of our patients (22/59) have undergone open cholecystectomy. This underscores the fact that in a developing country like India, open cholecystectomy is still performed in large numbers in peripheral hospitals. BDI possibly reflects the inadequacy of infrastructure and experience of the operating surgeon in these hospitals. In our observation, type A injury was more common with laparoscopic cholecystectomy whereas type E3 was more common with open cholecystectomy. This contradicts the earlier observation that laparoscopic surgery is associated with severe and more complex BDI [10, 11].

The majority of BDI go unrecognized during the index cholecystectomy [2–4]. When recognized, the basic principles of management are: convert to open in the case of laparoscopic cholecystectomy, assess the injury, perform an on-table cholangiogram, seek help from a more experienced surgeon and carry out an optimal repair [1]. Partial injury should be repaired over the T-tube [11]. Complete transection of the bile duct is best repaired by hepaticojejunostomy for a better long-term outcome. The latter procedure can pose technical difficulty because the bile duct, at this stage, is thin-walled and undilated. It is, therefore, desirable that the procedure should always be performed by a tertiary care specialist hepatobiliary surgeon. In one study, only 17 % of the repair was successful in the hands of primary surgeons compared to 94 % when performed by tertiary care surgeons [5]. Similar results have also been reported by other authors [6]. We managed six patients (group A) in whom the injury was detected during cholecystectomy. Our approach in these patients was similar to what has been recommended by other authors [1]. Four of the six patients were from other units or hospitals. Our team members reached out to offer expert help and carried out the required repairs. The feasibility and positive outcomes of such a ‘specialist outreach service’ have earlier been reported [7]. In the latter report, the ‘traveling surgeon’, when called upon to help, carried along with him some specialized surgical instruments for performing the repair. Such an approach is feasible in India, notwithstanding the poor infrastructural facilities present in some of these hospitals where the BDI has occurred.

 In the present series, type A (cystic duct leak) was the commonest form of injury seen in 18 patients belonging to group B. This may represent referral bias for ERCP that we routinely perform. In only one patient, CBD stone could be identified as the factor for cystic duct leak. In the remaining patients, clip failure was the possible cause. This contradicts the earlier perception that unsuspected CBD stone is the commonest predisposing factor for cystic duct ‘blow out’ [12]. Retained CBD stones have been reported in about 20 % of patients with cystic duct leak [13–16]. Management of type A injury includes ERC, EPT alone for low-grade leaks or with bile duct stenting. Additionally, drainage of intra-abdominal collection, when present, is achieved by US or CT guided percutaneously placed catheter or relaparoscopy [13–16]. Percutaneous placement of a catheter precedes ERC whereas relaparoscopy follows ERC during the same anesthesia. By this approach, four of the five patients in group B could be successfully salvaged.

Conventional approaches to type E injuries include control of sepsis, creation of controlled EBF and definitive repair after a waiting period ranging from 6 weeks to several months. The latter is to allow the inflammation to subside, fibrosis at the cut end to stabilize and the bile duct to dilate for an optimal hepaticojejunostomy [17–20]. An attempt at early repair was associated with high failure rates [4, 21–23]. Five patients in group B were managed in this manner. All these patients underwent laparotomy to drain out the peritoneal cavity as well as to create controlled EBF. At laparotomy, if feasible, we prefer to locate both the divided ends of the bile duct by gentle dissection and place the T-Tube. This was possible in three of the five patients. The remaining patients had tube hepaticostomy only. In our opinion, the T- tube has definite advantages over tube hepaticostomy. In the initial stages, it maintains external as well as internal drainage of bile. After cessation of peritubal/subhepatic bile leak, the T-tube could be clamped, thereby diverting the entire bile volume into the duodenum. The fluid and electrolyte loss could be minimized in addition to the obvious advantages of restoring the normal physiology of bile. A clamped T-tube had better acceptance by the patients in delaying the definitive repair to an optimum time. This was in contrast to the externally draining tube (hepaticostomy) that acted as a constant source of irritation to the patients who kept on nagging for an early repair. The delay also helped in better preparing the patients physically, mentally and financially for the definitive surgery.

Notwithstanding the conventional practice, some recent studies have highlighted the role of early repair of BDI in a select group of patients [6, 24, 25]. The result of early repair was comparable to the delayed approach in a stable patient in whom intra-abdominal sepsis, vascular and cautery injury could be excluded and, more importantly, when the surgery was performed by a ‘specialist hepatobiliary surgeon’. The exact timing of repair with respect to ‘early’ was not clearly defined, but the repair was carried out within 2 weeks of cholecystectomy. In the present study, early repair was carried out in 10 of the group B patients. All these patients had non-or minimally inflamed hepatic hilum either because of the completely ligated bile duct (three patients) or a controlled EBF (five patients). Two patients in group B with intact but ligated CBD were treated successfully for removal of the offending ligature and long-term T-tube placement. We could not find mention of this type of injury and, therefore, support this kind of approach in any of the available literature. End-to-end repair of transected CBD over the T-tube is associated with a high failure rate, hence not recommended by some authors [5, 26]. Proponents, on the other hand, proposed T-tube repair if there is no segmental loss of the bile duct [27, 28]. In addition to the simplicity of the technique, strictures following T-tube repair are salvageable either by radiological intervention or revision surgery, in the form of HJ without much difficulty [28]. A simple ligature around the CBD, in our opinion, devitalizes a lesser segment of the bile duct compared to a transected one. This segment should get revascularized over a period of time if patency of its lumen is maintained by an indwelling stent. However, a longer follow-up and a larger number of cases will be required to prove this point.

No attempt was made by us to exclude vascular injury in any of our patients. The implications of concomitant vascular injury with respect to repair of the bile duct have been highlighted by various authors [29–32]. These authors recommend that reconstruction of the arterial injury should be attempted whenever feasible. However, we strongly believe that a high anastomosis extending onto LHD in a well-collateralized hilum obviates the need for any such vascular repair that can otherwise be tedious and time-consuming. This view has also been shared by other authors [33].

Nine of the 20 patients in group C had prior operative intervention by the operating surgeon to correct the injury. Four of them had hepaticoduodenostomy. Published reports suggest that repair by the primary or the ‘injuring surgeon’ carries a poor outcome [5, 34]. Moreover, hepaticoduodenostomy almost always fails in the long run [35]. The only advantage of the latter anastomosis was that the opening in the duodenum provided access for obtaining cholangiogram (internal fis- tulogram). Such a modality of cholangiogram had not been reported earlier. The repair was performed at least 6 weeks after the index cholecystectomy. The reasons for this waiting were similar to what has been stated for patients in group B who underwent delayed repair. The high success rate of bile duct repair in the present study can be attributed to the appropriate timing, meticulous technique and tertiary care experience, a fact that has been highlighted by several authors [1, 18, 20, 35]. The only limitation in the present study, however, is the short follow-up period, i.e. 40 months. A follow-up of at least 5 years or more is desirable to make a final pronouncement of the results [36]

From this study we concluded that, the high success rate of bile duct repair in the present study can be attributed to the appropriate timing, meticulous technique and the tertiary care experience. If managed proper and timely then outcomes are very good.

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