Management of Gall Stone Disease

Section 1:Diagnosis of gallbladder stones:

·       We recommend to diagnose gallbladder stones by the characteristic symptoms of episodic attacks of severe pain in the right upper abdominal quadrant or epigastrium for at least 15-30 minutes with radiation to the right back or shoulder and a positive reaction to analgesics, (Conditional recommendation, very low certainty evidence,⁽¹⁾).

·       In a patient with a recent history of biliary pain, abdominal ultrasound should be performed, (Strong recommendation, high certainty evidence, ⁽¹⁾).  

·       In case of strong clinical suspicion of gallbladder stones and negative abdominal ultrasound, endoscopic ultrasound or magnetic resonance imaging may be performed, (Conditional recommendation, low certainty evidence, ⁽¹⁾).

Section 2. Diagnosis of ACC:

·       As no feature has sufficient diagnostic power to establish or exclude the diagnosis of ACC, it is recommended not to rely on a single clinical or laboratory finding, (Strong recommendation, high certainty evidence, (7)).

·       For the diagnosis of ACC, we suggest using a combination of detailed history, complete clinical examination, laboratory tests and imaging investigations, (Conditional recommendation, very low certainty evidence, ⁽⁷⁾).

·       We recommend the use of abdominal ultrasound (US) as the preferred initial imaging technique, (Strong recommendation, high certainty evidence, ⁽⁷⁾ ).

·       We suggest the use CT & MRI for the diagnosis of ACC, (Conditional recommendation, moderate certainty evidence, ⁽⁷⁾ ).

Section 3. Associated common bile duct stones: which tools to use for suspicion and diagnosis at presentation?

·       Common bile duct stones should be searched for in patients with jaundice, acute cholangitis or acute pancreatitis, (Strong recommendation, high certainty evidence, ⁽¹⁾).

·       We recommend against the use of elevated LFTs or bilirubin as the only method to identify CBDS in patients with CCh, (Strong recommendation, moderate certainty evidence, ⁽¹⁾).

·       Abdominal ultrasound should be the first imaging method when CBD stones are suspected, (Strong recommendation, and moderate certainty evidence, ⁽¹⁾).

·       We recommend that patients with moderate risk for CBDS undergo one of the following: preoperative magnetic resonance cholangiopancreatography (MRCP), ERCP, intraoperative cholangiography (IOC), or laparoscopic ultrasound (LUS), depending on local expertise and availability, (Strong recommendation, moderate certainty evidence, ⁽³⁾).  

·       Suspect Cholangitis is in patients with fever and a history of chills, together with abdominal pain and jaundice.  White blood cells, C-reactive protein and liver biochemical tests should be determined and abdominal ultrasound should be performed as the initial investigations, (Strong recommendation, moderate certainty evidence, ⁽¹⁾).

·       Suspect acute biliary pancreatitis in the presence of upper abdominal pain and altered pancreatic and liver biochemical tests in patients with gallbladder and/ or common bile duct stones, (Strong recommendation, moderate certainty evidence, ⁽³⁾).

·       The exclusion of bile duct stones by endoscopic ultrasound (or magnetic resonance cholangiopancreatography) may prevent the potential risks of endoscopic retrograde Cholangiopancreatograph (ERCP) in patients with acute biliary pancreatitis and suspected bile duct stones, (Conditional recommendation, low certainty evidence, ⁽³⁾).

Section 4:Medical therapy of gallstones:

·       We recommend against using bile acids alone or in combination with extracorporeal shock wave lithotripsy for dissolving gallbladder stones, (Strong recommendation, moderate certainty evidence, ⁽³⁾).

·       We suggest considering NOM, (i.e medical therapy with antibiotics and observation), for patients refusing surgery or those who are not suitable for surgery, (Conditional recommendation, low certainty evidence, ⁽⁷⁾).

Section 5. Surgical treatment of gallbladder stones:

·       We recommend cholecystectomy as the preferred option for treatment of symptomatic gallbladder stones, (Strong recommendation, moderate certainty evidence, ⁽³⁾).  

^·            Routine treatment is not recommended for patients with asymptomatic gallbladder ^{stones, (Conditional recommendation, very low certainty evidence, (3)).}

·       Asymptomatic patients with porcelain gallbladder may undergo cholecystectomy, (Conditional recommendation, very low certainty evidence, ⁽³⁾).

·        Cholecystectomy is not recommended in patients with gallbladder polyps ≤5 mm, (Strong recommendation, moderate certainty evidence, ⁽³⁾). 

·       Cholecystectomy should be performed in patients with gallbladder  polyps  ≥1 cm without or with gallstones regardless of their symptoms, (Strong recommendation, moderate certainty evidence, ^(3)). 

·       Cholecystectomy is considered in patients with asymptomatic gallbladder stones and gallbladder polyps 6-10 mm and in case of growing polyps, (Conditional recommendation, very low certainty evidence, ⁽³⁾).

·        Cholecystectomy may be recommended for asymptomatic patients with primary sclerosing cholangitis and gallbladder polyps irrespective of size, (Conditional recommendation, low certainty evidence, ⁽³⁾).

·       We recommend laparoscopic cholecystectomy as the first-line treatment for patients with ACC, (Strong recommendation, high certainty evidence, ⁽⁷⁾).

·       We recommend avoiding laparoscopic cholecystectomy in case of septic shock or absolute anaesthesiology contraindications, (Strong recommendation, high certainty evidence, ⁽⁸⁾).

·       We recommend laparoscopic cholecystectomy as the first-choice treatment in high risk patients with ACC. Immediate laparoscopic cholecystectomy is superior to percutaneous trans-hepatic gallbladder drainage (PTGBD) in this group of patients, (Strong recommendation, high certainty evidence, (8).

·       We suggest performing laparoscopic cholecystectomy for CCh patients with Child’s A and B cirrhosis, patients with advanced age (including more than 80 years old) and patients who are pregnant, (Conditional recommendation, low certainty evidence, ⁽⁸⁾).

·       We recommend performing gallbladder drainage in patients with ACC who are not suitable for surgery, as it converts a septic patient with ACC into a non-septic patient, (Strong recommendation, moderate certainty evidence, ⁽⁹⁾).

·       Delayed laparoscopic cholecystectomy is suggested after reduction of perioperative risks to decrease readmission for ACC relapse or gallstone-related disease, (conditional recommendation, very low certainty evidence, ⁽⁹⁾).

·       In patients with ACC who are not suitable for surgery, endoscopic trans-papillary gallbladder drainage (ETGBD) or ultrasound-guided transmural gallbladder drainage (EUS-GBD) should be considered safe and effective alternatives to PTGBD, if performed in high-volume centers by skilled endoscopists, (Strong recommendation, high certainty evidence, ⁽⁹⁾).   

Section 6. Timing of cholecystectomy in people with CCh:

·       Cholecystectomy should be performed as early as possible for patients with biliary colic, (Strong recommendation, moderate certainty evidence, ⁽³⁾). 

·       In ACC, in the presence of adequate surgical expertise, we recommend ELC be performed as soon as possible, within 7 days from hospital admission and within 10 days from the onset of symptoms, (Strong recommendation, moderate certainty evidence, ⁽⁷⁾).

·       In ACC, we suggest DLC to be performed beyond 6 weeks from the first clinical presentation, in case ELC cannot be performed (within 7 days of hospital admission and within 10 days of onset of symptoms), (conditional recommendation, very low certainty evidence, ⁽⁷⁾).

7: Endoscopic and surgical therapy of bile duct stones:

·       Endoscopic sphincterotomy and stone extraction is a recommended treatment of bile duct stones, (Strong recommendation, moderate certainty evidence, ⁽³⁾).

·       Intraoperative endoscopic retrograde cholangiopancreatography or laparoscopic bile duct exploration in combination with cholecystectomy are recommended as alternatives when adequate expertise is available, (conditional recommendation, moderate certainty evidence, ⁽³⁾).

·       In case of failed standard stone extraction, electrohydraulic or laser lithotripsy may be performed, (conditional recommendation, low certainty evidence, ⁽³⁾).

·       In the case of altered anatomy (e.g. previous Roux-en-Y anastomosis, bariatric surgery) percutaneous or endoscopic (balloon endoscopy-assisted) treatment of bile duct stones can be considered, (conditional recommendation, low certainty evidence, ⁽³⁾).

·       In the case of failed ERCP therapy, cholecystectomy combined with bile duct exploration should be performed, (Strong recommendation, moderate certainty evidence, ⁽³⁾).

·       In case of intraoperative detection of bile duct stones, we recommend bile duct exploration, trans-cystic stone extraction or endoscopic clearance as alternative treatment options, (conditional recommendation, moderate certainty evidence, ⁽³⁾).

·       Upon postoperative diagnosis of bile duct stones, endoscopic sphincterotomy and stone extraction are recommended, (strong recommendation, moderate certainty evidence, ⁽³⁾).

·       In case of surgical bile duct exploration, primary closure may be preferred over T-tube drainage in low risk cases, (conditional recommendation, low certainty evidence, ⁽³⁾).

·       In patients with simultaneous gallbladder and bile duct stones, early laparoscopic cholecystectomy should be performed within 72 h after preoperative ERCP for choledocholithiasis, (Strong recommendation, moderate certainty evidence, ⁽³⁾).

·       Treatment of cholangitis should include immediate broad spectrum antibiotics and biliary drainage, (Strong recommendation, moderate certainty evidence, ⁽³⁾).

·       Timing of biliary drainage depends on severity of the cholangitis and effects of medical therapy including antibiotics and may preferably be performed within 24 h; urgent drainage should be considered in case of severe cholangitis not responding to fluid resuscitation and intravenous antibiotics, (conditional recommendation, low certainty evidence, ⁽³⁾).

·       For biliary pancreatitis with suspected coexistent acute cholangitis antibiotics should be initiated, and endoscopic retrograde cholangiopancreatography with sphincterotomy and stone extraction should be performed, with timing depending on the severity of cholangitis but preferably within 24 hours, (Strong recommendation, high certainty evidence,  ⁽³⁾).

·       An endoscopic retrograde cholangiopancreatography is probably indicated in patients with biliary pancreatitis and obstructed bile duct, (conditional recommendation, low certainty evidence, ⁽³⁾).

·       An early endoscopic retrograde cholangiopancreatography is probably not indicated in patients with predicted severe biliary pancreatitis in the absence of cholangitis or obstructed bile duct, (conditional recommendation, low certainty evidence, ⁽³⁾).

·       In patients with suspected biliary pancreatitis without cholangitis, endoscopic ultrasound or magnetic resonance cholangiopancreatography may prevent potential endoscopic retrograde cholangiopancreatography and prevent its risks if no stones are detected, (conditional recommendation, low certainty evidence, ⁽³⁾).

·       Cholecystectomy during the same hospital admission is recommended as the preferred option in patients with mild acute biliary pancreatitis, (Strong recommendation, high certainty evidence, ⁽³⁾).

·       We recommend removing CBDS, either preoperatively, intraoperatively, or postoperatively, according to the local expertise and the availability of several techniques, (conditional recommendation, high certainty evidence, ⁽⁸⁾).

Section 8: Bile duct injuries:

·       Suspected bile duct injury after surgery warrants urgent investigation including laboratory tests (white blood count, bilirubin, liver enzymes) and imaging (abdominal ultrasound, contrast-enhanced CT, magnetic resonance cholangiopancreatography) to detect bile leak and/or intra-abdominal fluid, (Strong recommendation, moderate certainty evidence, ⁽³⁾).

·       Primary surgical repair of intraoperatively recognized bile duct lesions A, B or C (Table 3) can be carried out, if surgical expertise is available. For type D lesions intraoperative consultation of an expert center is mandatory; merely sub-hepatic drainage is advised and the patient is referred to an expert center. Late reconstruction (after 6-8 weeks) is advised, often with hepatico-jejunostomy, (conditional recommendation, low certainty evidence, ⁽³⁾).