Background
Guideline scope and methods
Question n° 1: What are the general recommendations to minimize the risk of BDI during laparoscopic cholecystectomy in elective and emergency settings? | ||
Team leader Federico Coccolini | Co-leads Federico Gheza and Andrea De Palma | Working group members Miklosh Bala, Ofir Ben-Ishay, Marco Ceresoli, Stefania Cimbanassi, Philip de Reuver, Bertrand Le Roy, Chichom Mefire, Andrew Kirkpatrick, Carlos Ordoñez, Richard ten Broek and Dieter Weber |
Question n° 2: What are the reported BDI rates during LC in emergency and elective settings and when should a surgical team review its current practice to improve the standards of care? | ||
Team leader Aleix Martinez-Perez | Co-leads Salomone Di Saverio | Working group members Luca Ansaloni, Daniel Casanova, David Fuks, Carlos Domingo, Manuel Planells, Yoram Kluger, Filippo Landi, Andrew B. Peitzman, Sandro Rizoli and Mario Serradilla-Martin |
Question n° 3: Which classifications of BDI should be adopted and what is the minimum required information that the surgeon must report after diagnosing BDI during laparoscopic cholecystectomy? | ||
Team leader Nicola de’Angelis | Co-leads Nassiba Beghdadi | Working group members Fikri M. Abu-Zidan, Marc-Antoine Allard, Francesco Brunetti, Maria Clotilde Carra, Valerio Celentano, Christian Cotsoglou, Federica Gaiani, Reza Kianmanesh, Real Lapointe, Bruno M. Pereira, Luca Portigliotti and Giorgos Veloudis |
Question n° 4: What are the surgical management strategies and timing for intraoperatively diagnosed BDI? | ||
Team leader Daniele Sommacale | Co-leads Raffaele Brustia | Working group members Ruslan Alikhanov, Alessandro Ferrero, Felice Giuliante, Stefan Hofmeyr, Mohammed Lamine Sissoko, Serena Langella, Kazuhiro Niramatsu, Juan Pekolj, Fabiano Perdigao, Behnam Sanei, Olivier Scatton, Boris Sakakushev and Roberto Valinas |
Question n° 5: What is the recommended type and duration of antibiotic regimen in cases of BDI? | ||
Team leader Oreste M. Romeo | Co-leads Tullio Piardi and Rami Rhaiem | Working group members Niccolò Allievi, Roland Andersson, Enrico Andolfi, Walter Biffl, Raul Coimbra, Gustavo Fraga, Angela Gurrado, Michele Pisano, Raffaele Romito, Anne-Sophie Schnek and Giulio Vitali |
Question n° 6: Which are the clinical, biochemical, and imaging investigations required for the postoperative diagnosis of BDI? | ||
Team leader Fausto Catena | Co-leads Belinda de Simone | Working group members Giuliana Amaddeo, Osvaldo Chiara, Roberto Bini, Gian Luigi de’Angelis, Francesco Decembrino, Federica Gaiani, Roberta Iadarola, Alain Luciani, Ronald V. Maier, Franca Patrizi, Juan Carlos Puyana, Iradj Sobhani, Mario Testini and Luigi Zorcolo |
Question n° 7: What are the surgical management strategies and timing for postoperatively diagnosed BDI? | ||
Team leader Riccardo Memeo | Co-leads Maria Conticchio and Francesco Marchegiani | Working group members Mohammad Azfar, Amine Benkabbou, Raffaele Brustia, Salomone Di Saverio, Paschalis Gavriilidis, Ewen Harrison, Umberto Maggi, Angel Henriquez, Stefan Hofmeyr, Jeffry L Kashuk, Fernando Machado, Patrick Pessaux, Behnam Sanei and Daniele Sommacale |
BDI key questions
Q1. What are the general recommendations to minimize the risk of BDI during laparoscopic cholecystectomy in elective and emergency settings?
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Statements:
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1.1. The use of the CVS during LC (achieving all 3 components) is the recommended approach to minimize the risk of BDIs.
Strong recommendation, low quality of evidence (GRADE 1C)
1.2. If the CVS is not achievable during a difficult LC, a bailout procedure, such as STC, should be considered.
Strong recommendation, moderate quality of evidence (GRADE 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.
Weak recommendation, moderate quality of evidence (GRADE 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.
Weak recommendation, high quality of evidence (GRADE 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.
Weak recommendation, low quality of evidence (GRADE 2C).
1.6. In patients presenting with AC, the optimal timing for cholecystectomy is within 48 h, and no more than 10 days from symptom appearance. Strong recommendation, good quality of evidence (GRADE 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.
Weak recommendation, low quality of evidence (GRADE 2C)
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Literature review
Critical view of safety
Bailout procedures
Intraoperative biliary imaging
Optimal timing of LC for acute cholecystitis
Q2. What are the reported BDI rates during LC in emergency and elective settings and when should a surgical team review its current practice to improve the standards of care? | |
Statement: | |
2.1. Based on large nationwide databases and systematic review 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. Strong recommendation, low quality of evidence (GRADE 1C) |
Literature review
Q3. Which classifications of BDI should be adopted, and what is the minimum required information that the surgeon must report after diagnosing BDI during LC? | |
Statements: | |
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. Strong recommendation, low quality of evidence (GRADE 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: 1. The clinical context and indication for cholecystectomy 2. Intraoperative findings 6. Operative data (e.g., operative time, blood loss, energy device used for dissection, need for conversion) 7. Drawing of the BDI with biliary drain placement (if used) 8. Videotape of the procedure (whenever available). Strong recommendation, low quality of evidence (GRADE 1C) |
Literature review
BDI classification systems | |||||||||
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Bismuth [92, 93] | Strasberg [90] | McMahon [94] | Bergman [95] | Csendes [97] | Stewart-Way [98, 103] | Hannover [17] | Lau [99] | ATOM [100] | |
Bile leakage | |||||||||
Cystic duct leak or leaks from small ducts in liver bed | A | A | Type I | Type A | Type 1 | NMBD | |||
Occlusion of an aberrant RHD | B | Type 2 | |||||||
Leak from an aberrant RHD | C | ||||||||
Lateral injury to CBD < 50% diameter | D | Type 2 | |||||||
Laceration > 25% of CBD | Major bile duct injury | B | |||||||
Transection of CBD or CHD | Major bile duct injury | D | Type III | Class II/III | Type D | Type 3 | |||
Resection od more than 10 mm of the CBD | Type IV | ||||||||
Tangential injury of the CBD | Type C | ||||||||
Right/left hepatic duct or sectoral duct injuries | Type 4 | ||||||||
Laceration < 25% of CBD | Minor bile duct injury | Class I | |||||||
Laceration of cystic-CBD junction | Minor bile duct injury | Type II | |||||||
Bile stricture | |||||||||
Stenosis of the main bile duct without injury (caused by a clip) | Type B | ||||||||
CBD stump > 2 cm | Type I | EI | MBD 1 | ||||||
CBD stump < 2 cm | Type II | E2 | MBD 2 | ||||||
Ceiling of the biliary confluence is intact | Type III | E3 | MBD 3 | ||||||
Ceiling of the confluence is destroyed | Type IV | E4 | MBD 4 | ||||||
Type I, II or III + stricture of an isolated right duct | Type V | E5 | |||||||
Development of post-operative CBD stricture | Major bile duct injury | C | Type E | ||||||
Vascular lesion | |||||||||
Right hepatic artery + RHD transected | Class IV | Type D | Type 5 | VBI+ |
How to classify BDI
Anatomical characteristics | Time of detection | Mechanism | |||||||||
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Anatomic level | Type and extent of injury | Vasculobiliary injury (yes = VBI+) and name of injured vessel (RHA, LHA, CHA, PV, MV); (no = VBI−) | Ei (de visu, bile leak, IOC) | Ep | L | Me | ED | ||||
Occlusion | Division | ||||||||||
C | P* | C | P* | LS** | |||||||
MBD | |||||||||||
1 | |||||||||||
2 | |||||||||||
3 | |||||||||||
4 | |||||||||||
5 | |||||||||||
6 | |||||||||||
NMBD |
How to describe BDI
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Bile drainage from a location other than the gallbladder
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Bile draining from a tubular structure
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A second cystic artery or large artery posterior to the cystic duct
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A short cystic duct
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A bile duct that can be traced to the duodenum
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Severe hemorrhage or inflammation.
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Failure to opacify the proximal hepatic duct or the cystic duct
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Identification of an extra bile duct, an aberrant bile duct, or duct of Luschka
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Ductal abnormalities: wide cystic duct (which may be the common bile duct), accessory bile duct, second cystic duct (which may be the common hepatic duct), and abnormal gallbladder infundibulum that may indicate that the common bile duct was dissected.
Q4. What are the surgical management strategies and timing for intraoperatively diagnosed BDI? | |
Statements: | |
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. Weak recommendation, moderate quality of evidence (GRADE 2B) 4.2. Direct repair with or without T-tube placement may be considered in cases of minor BDIs. Hepaticojejunostomy should be considered the treatment of choice in cases of major BDIs. Strong recommendation, low quality of evidence (GRADE 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. Strong recommendation, low quality of evidence (GRADE 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. Weak recommendation, very low quality of evidence (GRADE 2C) 4.5. The repair of complex injuries (e.g., vasculobiliary) should be delayed and not attempted intraoperatively, even by expert HPB surgeons. Weak recommendation, low quality of evidence (GRADE 2C) |
Literature review
Management of intraoperatively diagnosed BDI
Management of concomitant vascular injuries
Q5. What is the recommended type and duration of antibiotic regimen in cases of BDI? | |
Statements: | |
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. Weak recommendation, very low quality of evidence (GRADE 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 (4th-generation cephalosporins) are recommended, with further adjustments according to antibiograms. Strong recommendation, low quality of evidence (GRADE 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 cases of shock and using fluconazole in fragile patients and cases of delayed diagnosis. Strong recommendation, low quality of evidence (GRADE 1C) 5.4. In severe complicated intra-abdominal sepsis, open abdomen can be considered an option for patients with organ failure and gross contamination. Weak recommendation, low and very low quality of evidence (GRADE 2C) |
Literature review
Antibiotic therapy in case of intraoperatively diagnosed BDI
Antibiotic therapy in case of postcholecystectomy biliary ductal stenosis
Antibiotic therapy in case of biliary leakage
Q6. Which are the clinical, biochemical, and imaging investigations required for the postoperative diagnosis of BDI? | |
Statements: | |
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). Weak recommendation, low quality of evidence (GRADE 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. Weak recommendation, low quality of evidence (GRADE 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. Weak recommendation, moderate quality of evidence (GRADE 2B) |
Literature review
Clinical signs and symptoms of BDI
Biochemical tests for the diagnosis of BDI
Imaging for postoperative diagnosis of BDI
Q7. What are the surgical management strategies and timing for postoperatively diagnosed BDI? | |
Statements: | |
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 non-operative management during the first hours is an option. If no drain is placed during surgery, percutaneous treatment of the collection with drain placement can be useful. Weak recommendation, low quality of the evidence (GRADE 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. Strong recommendation, low quality of the evidence (GRADE 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. Strong recommendation, low quality of the evidence (GRADE 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), Roux-en-Y hepaticojejunostomy should be performed. Weak recommendation, low quality of the evidence (GRADE 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. Weak recommendation, low quality of the evidence (GRADE 2C) 7.6. When major BDIs present as diffuse biliary peritonitis, urgent abdominal cavity lavage and drainage are required as the first step of treatment to achieve infection source control. Strong recommendation, low quality of the evidence (GRADE 1C) |
Literature review
Management of minor BDIs
Role of ERCP in BDI management
Management of major BDIs
Outcomes of BDI treatment
Medicolegal aspects
Conclusions
Topic | Statements | Grade |
---|---|---|
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 (4th-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 |