Guideline sources The following summarized guidelines for the evaluation and management of biliary stricture are prepared by our editorial team based on guidelines from the American College of Gastroenterology (ACG 2023), the European Society of Medical Oncology (ESMO 2023; 2016), the Thai Association for Gastrointestinal Endoscopy (TAGE/T-CAP 2022), the European Society of Gastrointestinal Endoscopy (ESGE 2021; 2020; 2019; 2018), the Thai Association for Gastrointestinal Endoscopy (TAGE/T-CAP/DEST 2020), the British Society of Gastroenterology (BSG 2019), the American College of Radiology (ACR 2019), the Infectious Diseases Society of America (IDSA 2016), the American Society for Gastrointestinal Endoscopy (ASGE 2015), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES 2010). 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Guidelines 1. Diagnostic investigations Evaluation of extrahepatic strictures (abdominal ultrasound): consider obtaining abdominal ultrasound in the initial evaluation to identify biliary obstruction in patients with biliary tract cancer. E https://web.pathway.md/diseases/rec5jsaxkrOGmSEpV 1/6 6/29/23, 3:17 AM Biliary stricture Pathway Evaluation of extrahepatic strictures (CT/MRI): consider obtaining contrast-enhanced CT or MRI for the detection and characterization of a mass and to determine the resectability of malignant lesions. B Evaluation of extrahepatic strictures (ERCP): consider performing ERCP to establish the etiology in patients with distal biliary strictures. Perform ERCP-guided tissue acquisition when biliary drainage is required. B Evaluation of extrahepatic strictures, EUS with FNA: As per ACG 2023 guidelines: Perform EUS with fine-needle sampling (aspiration or biopsy) over ERCP to evaluate for malignancy in patients with extrahepatic biliary stricture due to an apparent or suspected pancreatic mass. B Consider performing EUS with fine-needle biopsy or EUS with FNA plus rapid on-site evaluation over FNA without rapid on-site evaluation to evaluate for malignancy in patients with extrahepatic biliary stricture due to an apparent or suspected pancreatic mass. C As per T-CAP/TAGE/DEST 2020 guidelines: Consider performing EUS to establish the etiology in patients with distal biliary strictures. B Perform EUS-guided FNA when cross-sectional imaging reveals a mass associated with the stricture or when endoscopic retrograde cholangio-pancreatography-guided tissue acquisition is unsuccessful. A Evaluation of extrahepatic strictures (cholangioscopy and intraductal ultrasound): consider performing peroral cholangioscopy and intraductal ultrasound to improve the characterization of distal biliary strictures. C Evaluation of perihilar strictures: perform multimodality sampling over brush cytology alone during the index ERCP in patients with a suspected malignant perihilar stricture. B Evaluation of indeterminate strictures: As per TAGE 2022 guidelines, perform direct visualization or targeted biopsy via cholangioscopy to diagnose malignant biliary strictures in patients with an indeterminate biliary stricture. B Consider using image enhancement during cholangioscopy to increase the diagnostic sensitivity of visual impressions of malignant biliary strictures. B Show 3 more As per ASGE 2015 guidelines, consider performing peroral cholangioscopy with directed biopsy as an adjunctive technique for characterizing indeterminate biliary strictures. C Evaluation of primary sclerosing cholangitis: obtain MRCP as the principal imaging modality for the evaluation of patients with suspected PSC. Consider performing ERCP in patients with biliary strictures requiring tissue acquisition (such as cytological brushings). Perform pathological sampling of suspicious strictures in patients undergoing ERCP for dominant strictures. A Evaluation of postoperative biliary obstruction: obtain a specialized multidisciplinary evaluation in patients with biliary tract cancer and postoperative biliary obstruction to determine the location of the obstruction, evaluate for recurrence, and determine the optimal approach to drainage. B https://web.pathway.md/diseases/rec5jsaxkrOGmSEpV 2/6 6/29/23, 3:17 AM Biliary stricture Pathway 2. Therapeutic procedures Biliary drainage, extrahepatic obstruction, benign causes: As per ACG 2023 guidelines, perform placement of a fully covered self-expanding metallic stent over multiple plastic stents in parallel to reduce the procedures required for long-term treatment in patients with extrahepatic stricture caused by a benign condition. B As per T-CAP/TAGE/DEST 2020 guidelines, perform endoscopic biliary drainage for the treatment of cholangitis and relief of cholestasis. Consider performing endoscopic stenting as the primary treatment of benign biliary strictures. A Show 3 more As per ESGE 2019 guidelines, consider performing placement of temporary multiple side-by- side plastic stents or a fully covered self-expandable metal stent in patients with chronic pancreatitis-related benign biliary strictures. C As per ASGE 2015 guidelines, perform ERCP with dilation and stent placement in patients with benign biliary strictures. B Biliary drainage, extrahepatic obstruction, malignant causes: As per ACG 2023 guidelines, avoid performing routine preoperative biliary drainage in patients with extrahepatic stricture caused by resectable pancreatic cancer or cholangiocarcinoma. Perform preoperative biliary drainage in selected patients, including patients with acute cholangitis, severe pruritus, very high serum bilirubin levels, and patients undergoing neoadjuvant therapy or experiencing another anticipated delay to surgery. D Show 2 more As per ESMO 2023 guidelines: Perform biliary drainage and subsequent treatment in patients with biliary tract cancer and biliary obstruction. Perform percutaneous transhepatic drainage when endoscopic access is not possible. B Prefer a metal stent in patients with a life expectancy of > 3 months. B Inform patients of the likely duration of stent patency and symptoms and signs of biliary obstruction or infection. B As per ESGE 2021 guidelines, perform retrograde cholangiopancreatography with self- expandable metal stent placement in patients with ampullary tumors and biliary obstruction in palliative settings. A As per T-CAP/TAGE/DEST 2020 guidelines, perform endoscopic biliary drainage for the treatment of cholangitis and relief of cholestasis. A Show 9 more As per ESGE 2018 guidelines, do not perform preoperative biliary drainage routinely in patients with malignant extrahepatic biliary obstruction. Reserve preoperative biliary drainage for patients with cholangitis, severe symptomatic jaundice (intense pruritus), delayed surgery, or before neoadjuvant chemotherapy in jaundiced patients. D Show 6 more Biliary drainage, perihilar obstruction: https://web.pathway.md/diseases/rec5jsaxkrOGmSEpV 3/6 6/29/23, 3:17 AM Biliary stricture Pathway As per ACG 2023 guidelines, insufficient evidence to recommend for or against ERCP versus percutaneous transhepatic biliary drainage in patients with perihilar stricture due to suspected malignancy. Show 2 more As per ACR 2019 guidelines, perform placement of a percutaneous internal/external biliary catheter in patients with malignant hilar obstruction (such as Klatskin tumor). B As per ESGE 2018 guidelines, perform drainage of malignant hilar strictures in high volume centers with a multidisciplinary hepatobiliary team. B Show 4 more Removal of biliary stents: perform ERCP with planned stent exchange or removal in patients with benign distal biliary strictures. B Show 2 more Adjunctive therapies: recognize that endo-biliary photodynamic therapy, B radiofrequency ablation, B and drug-eluting stents are considered investigational therapies for malignant distal biliary strictures. B 3. Perioperative care Preprocedural antibiotic prophylaxis: As per ESGE 2020 guidelines: Do not administer routine antibiotic prophylaxis before ERCP. D Consider administering antibiotic prophylaxis (with an agent active against Gram-negative bacteria and adapted as much as possible to local epidemiology) before ERCP in case of anticipated incomplete biliary drainage, in severely immunocompromised patients, and when performing cholangioscopy. C As per ASGE 2015 guidelines, administer antibiotic prophylaxis before ERCP in patients with known or suspected biliary obstruction, where there is a possibility of incomplete biliary drainage. Administer antibiotics covering biliary flora, such as enteric gram-negative organisms and enterococci, and continue after the procedure if biliary drainage is incomplete. B Pre-stenting sphincterotomy: avoid performing routine endoscopic biliary sphincterotomy before the insertion of a single plastic or uncovered/partially covered self-expandable metallic stent for relief of biliary obstruction. D 4. Surgical interventions Indications for surgery (hepatic aspergillosis): consider performing surgical intervention in patients with extrahepatic or perihepatic biliary obstruction caused by hepatic aspergillosis. C https://web.pathway.md/diseases/rec5jsaxkrOGmSEpV 4/6 6/29/23, 3:17 AM Biliary stricture Pathway Indications for surgery (sphincter of Oddi dysfunction): consider performing laparoscopic cholecystectomy in patients with symptoms of biliary obstruction without evidence of gallstones but with abnormal gallbladder emptying. C 5. Specific circumstances Patients with an indwelling biliary catheter: recognize that cholangitis in patients with an indwelling biliary stent suggests recurrent biliary obstruction and may require early endoscopic re- intervention. B Show 3 more Clinical findings Symptoms Past medical history Dark urine Autoimmune pancreatitis Fever Cholangiocarcinoma Generalized pruritus Chronic pancreatitis Nausea Gallbladder cancer Pale stools Liver metastasis RUQ pain PSC Vomiting Pancreatic cancer Ocular exam Integument exam Scleral icterus Jaundice Lab findings Imaging findings serum ALP Bile duct stricture serum TBIL Dilated bile ducts References 1. B Joseph Elmunzer, Jennifer L Maranki, Victoria G mez et al. ACG Clinical Guideline: Diagnosis and Management of Biliary Strictures. Am J Gastroenterol. 2023 Mar 1;118 3 405 426. Open 2. Jean-Marc Dumonceau, Andrea Tringali, Ioannis S Papanikolaou et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy ESGE Clinical Guideline Updated October 2017. Endoscopy. 2018 Sep;50 9 910 930. Open 3. Yousuke Nakai, Hiroyuki Isayama, Hsiu-Po Wang et al. International consensus statements for endoscopic management of distal biliary stricture. J Gastroenterol Hepatol. 2020 Jun;35 6 967 979. Open https://web.pathway.md/diseases/rec5jsaxkrOGmSEpV 5/6 6/29/23, 3:17 AM Biliary stricture Pathway 4. Jean-Marc Dumonceau, Myriam Delhaye, Andrea Tringali et al. Endoscopic treatment of chronic pancreatitis: European Society of Gastrointestinal Endoscopy ESGE Guideline Updated August 2018. Endoscopy. 2019 Feb;51 2 179 193. Open 5. ASGE Standards of Practice Committee, Mouen A Khashab, Krishnavel V Chithadi et al. Antibiotic prophylaxis for GI endoscopy. Gastrointest Endosc. 2015 Jan;81 1 81 9. Open 6. ASGE Standards of Practice Committee, Krishnavel V Chathadi, Vinay Chandrasekhara et al. The role of ERCP in benign diseases of the biliary tract. Gastrointest Endosc. 2015 Apr;81 4 795 803. Open 7. Geoffroy Vanbiervliet, Marin Strijker, Marianna Arvanitakis et al. Endoscopic management of ampullary tumors: European Society of Gastrointestinal Endoscopy ESGE Guideline. Endoscopy. 2021 Apr;53 4 429 448. Open 8. A Vogel, J Bridgewater, J Edeline et al. Biliary tract cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023 Feb;34 2 127 140. Open 9. Jean-Marc Dumonceau, Christine Kapral, Lars Aabakken et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy ESGE Guideline. Endoscopy. 2020 Feb;52 2 127 149. Open 10. Patterson TF, Thompson GR rd, Denning DW et al. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2016 Aug 15;63 4):e1-e60. Open 11. Phonthep Angsuwatcharakon, Santi Kulpatcharapong, Jong H Moon et al. Consensus guidelines on the role of cholangioscopy to diagnose indeterminate biliary stricture. HPB Oxford). 2022 Jan;24 1 17 29. Open 12. D Wayne Overby, Keith N Apelgren, William Richardson et al. SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc. 2010 Oct;24 10 2368 86. Open 13. Chapman MH, Thorburn D, Hirschfield GM et al. British Society of Gastroenterology and UK PSC guidelines for the diagnosis and management of primary sclerosing cholangitis. Gut. 2019 Aug;68 8 1356 1378. Open 14. J W Valle, I Borbath, S A Khan et al. Biliary cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v28-v37. Open 15. Expert Panel on Interventional Radiology:, Alexandra H Fairchild, Eric J Hohenwalter et al. ACR Appropriateness Criteria Radiologic Management of Biliary Obstruction. J Am Coll Radiol. 2019 May;16 5S S196 S213. Open 16. Bing Hu, Bo Sun, Qiang Cai et al. Asia-Pacific consensus guidelines for endoscopic management of benign biliary strictures. Gastrointest Endosc. 2017 Jul. Open https://web.pathway.md/diseases/rec5jsaxkrOGmSEpV 6/6