Table 4 Summary of the consensus statements on BDI detection and management

Minimize the risk of BDI during LC

1.1. The use of the CVS during LC (achieving all 3 components) is the recommended approach to minimize the risk of BDIs.

1C

1.2. If the CVS is not achievable during a difficult LC, a bailout procedure, such as STC, should be considered.

1B

1.3. Conversion to open surgery may be considered during a difficult LC whenever the operating surgeon cannot manage the procedure laparoscopically. However, there is insufficient evidence to support conversion to open surgery as a strategy to avoid or reduce the risk of BDI in difficult LCs.

2B

1.4. Intraoperative IOC is useful to recognize bile duct anatomy and choledocholithiasis in cases of intraoperative suspicion of BDI, misunderstanding of biliary anatomy, or inability to see the CVS, but routine use to reduce the BDI rate is not yet recommended.

2A

1.5. Intraoperative ICG-C is a promising noninvasive tool to recognize bile duct anatomy and vascular structures, but routine use to reduce the BDI rate is not yet recommended.

2C

1.6. In patients presenting with AC, the optimal timing for LC is within 48 h, and no more than 10 days from symptom appearance.

1A

1.7. In patients with at-risk conditions (e.g., scleroatrophic cholecystitis, Mirizzi syndrome), an exhaustive preoperative work-up prior cholecystectomy is mandatory in order to discuss and balance the risks/benefits ratio of the procedure.

2C

BDI rates and review of current practice in general surgery unit

2.1. Based on large nationwide databases and systematic reviews of the literature, major BDIs occur in 0.1% of elective LC and 0.3% of emergency LC. If considering all types of BDIs, rates are 0.4% and 0.8% for elective and emergency settings, respectively. When a surgical team experiences an increased rate of BDIs, a careful review of the current practice is mandatory to critically analyze the possible causes and implement educational, training, and technical solutions to improve the standards of care.

1C

BDI classifications

BDI reporting

3.1. We recommend knowing Strasberg’s classification, which remains the most commonly used classification for BDIs, and the ATOM classification, which represents the most recent and complete classification; the implementation of the ATOM classification should be promoted in the near future.

1C

3.2. The ideal operative report must maximize the amount of intraoperative detail given to describe the BDI. The following should minimally be included:

- The clinical context and indication for cholecystectomy

- Intraoperative findings

- The anatomical landmarks of the CVS

- Any anatomical variation of the biliary tract

- Cholangiography findings (if performed)

- Operative data (e.g., operative time, blood loss, energy device used, need for conversion)

- Drawing of the BDI with biliary drain placement (if used)

- Videotape of the procedure (whenever available).

1C

Intraoperatively detected BDI management

4.1. We recommend the selective use of adjuncts for biliary tract visualization (e.g., IOC, ICG-C) during difficult LC or whenever BDI is suspected to increase the rate of intraoperative diagnosis. The opinion of another surgeon should also be considered.

2B

4.2. Direct repair with or without T-tube placement may be considered in cases of minor BDIs. Hepaticojejunostomy should be considered as the treatment of choice in cases of major BDIs.

1C

4.3. Early BDI repair (on-table up to 72 h) may be considered in cases of appropriate surgical indications and expertise. Referral to an HPB center should be considered if sufficient HPB expertise is not available locally.

1C

4.4. Systematic immediate repair of isolated injuries of the right hepatic artery is not recommended, and the benefit/risk ratio should be evaluated carefully.

2C

4.5. The repair of complex injuries (e.g., vasculo-biliary) should be delayed and not attempted intraoperatively even by expert HPB surgeons.

2C

Antibiotic regimen

5.1. In cases of suspected BDI during elective LC without a history of previous biliary drainage, antibiotic therapy may be considered using broad-spectrum antibiotics.

2C

5.2. In patients with previous biliary infection (i.e., cholecystitis, cholangitis) and patients with preoperative endoscopic stenting, ENBD, or PTBD at risk of developing local and systemic sepsis, broad-spectrum antibiotics (4^th-generation cephalosporins) are recommended, with further adjustments according to antibiograms.

1C

5.3. In patients with biliary fistula, biloma, or bile peritonitis antibiotics should be started immediately (within 1 h) using piperacillin/tazobactam, imipenem/cilastatin, meropenem, ertapenem, or aztreonam associated with amikacin in case of shock, and using fluconazole in cases of fragile patients or delayed diagnosis.

1C

5.4. In severe complicated intra-abdominal sepsis, open abdomen can be considered as an option for patients with organ failure and gross contamination.

2C

Clinical, biochemical, and imaging investigations for suspected BDI

6.1. We recommend a prompt investigation of patients who do not rapidly recover after LC, with alarm symptoms being fever, abdominal pain, distention, jaundice, nausea and vomiting (depending on the type of BDI).

2C

6.2. The assessment of liver function tests, including serum levels of direct and indirect bilirubin, AST, ALT, ALP, GGT, and albumin, is suggested in patients with clinical signs and symptoms suggestive of BDI after LC. In critically ill patients, the serum levels of CRP, PCT, and lactate may help in the evaluation of the severity of acute inflammation and sepsis and in monitoring the response to treatment.

2C

6.3. Abdominal triphasic CT is suggested as the first-line diagnostic imaging investigation to detect intra-abdominal fluid collections and ductal dilation. It may be complemented with the addition of CE-MRCP to obtain the exact visualization, localization and classification of BDI, which is essential for planning a tailored treatment.

2B

Postoperatively detected BDI management

7.1. In the case of minor BDIs (e.g., Strasberg A-D), if a drain is placed after surgery and a bile leak is noted, an observation period and nonoperative management during the first hours is an option. If no drain is placed during surgery, the percutaneous treatment of the collection with drain placement can be useful.

2C

7.2. For minor BDIs, if no improvements or worsening of symptoms occurs during the clinical observation period after percutaneous drain placement, endoscopic management (by ERCP with biliary sphincterotomy and stent placement) becomes mandatory.

1C

7.3. In major BDIs (e.g., Strasberg E1–E2) diagnosed in the immediate postoperative period (within 72 h), we recommend referral to a center with expertise in HPB procedures, if that expertise is locally unavailable. An urgent surgical repair with bilioenteric anastomosis Roux-en-Y hepaticojejunostomy could then be performed.

1C

7.4. In major BDIs diagnosed between 72 h and 3 weeks, we recommend percutaneous drainage of the fluid collections whenever present, targeted antibiotics, and nutritional support. During this period, an ERCP (sphincterotomy with or without stent) can be considered to reduce the pressure gradient in the biliary tree and a PTBD could be useful for septic patients with a complete obstruction of the common bile duct. After a minimum of 3 weeks, if the patient’s general conditions allow and the acute or subacute situation is resolved (e.g., closure of the biliary fistula), the Roux-en-Y hepaticojejunostomy should be performed.

2C

7.5. When major BDIs are recognized late after the index LC and there are clinical manifestations of stricture, Roux-en-Y hepaticojejunostomy should be performed.

2C

7.6. When major BDIs present as diffuse biliary peritonitis, urgent abdominal cavity lavage and drainage are required as first step of treatment to achieve infection source control.

1C