ERCP plus endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage for malignant hilar biliary obstruction: a multicenter observational open-label study

Abstract

Background Endoscopic retrograde cholangiopancreatography (ERCP) may not provide complete biliary drainage in patients with Bismuth III/IV malignant hilar biliary obstruction (MHBO). Complete biliary drainage is accomplished by adding percutaneous transhepatic biliary drainage (PTBD). We prospectively compared recurrent biliary obstruction (RBO) rates between combined ERCP and endoscopic ultrasound-guided biliary drainage (EUS-BD) vs. bilateral PTBD.

Methods Patients with MHBO undergoing endoscopic procedures (group A) were compared with those undergoing bilateral PTBD (group B). The primary outcome was the 3-month RBO rate.

Results 36 patients were recruited into groups A (n = 19) and B (n = 17). Rates of technical and clinical success, and complications of group A vs. B were 84.2 % (16/19) vs. 100 % (17/17; P = 0.23), 78.9 % (15/19) vs. 76.5 % (13/17; P > 0.99), and 26.3 % (5/19) vs. 35.3 % (6/17; P = 0.56), respectively. Within 3 and 6 months, RBO rates of group A vs. group B were 26.7 % (4/15) vs. 88.2 % (15/17; P  = 0.001) and 22.2 % (2/9) vs. 100 % (9/9; P = 0.002), respectively. At 3 months, median number of biliary reinterventions in group A was significantly lower than in group B (0 [interquartile range] 0–1 vs. 1 [1–2.5]), respectively (P < 0.001). Median time to development of RBO was longer in group A than in group B (92 [56–217] vs. 40 [13.5–57.8] days, respectively; P  =  0.06).

Conclusions Combined ERCP and EUS procedures provided significantly lower RBO rates at 3 and 6 months vs. bilateral PTBD, with similar complication rates and no significant mortality difference.

Publication History

Received: 28 December 2019

Accepted: 08 June 2020

Accepted Manuscript online:
08 June 2020

Article published online:
08 July 2020

• References

• 1 Rerknimitr R, Angsuwatcharakon P, Ratanachu-ek T. et al. Asia-Pacific consensus recommendations for endoscopic and interventional management of hilar cholangiocarcinoma. J Gastroenterol Hepatol 2013; 28: 593-607
• 2 Puli SR, Kalva N, Pamulaparthy SR. et al. Bilateral and unilateral stenting for malignant hilar obstruction: a systematic review and meta-analysis. Indian J Gastroenterol 2013; 32: 355-362
• 3 Dumonceau JM, Tringali A, Papanikolaou IS. et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline – Updated October 2017. Endoscopy 2018; 50: 910-930
• 4 Nakai Y, Kogure H, Isayama H. et al. Endoscopic ultrasound-guided biliary drainage for unresectable hilar malignant biliary obstruction. Clin Endosc 2019; 52: 220-225
• 5 Kongkam P, Tasneem AA, Rerknimitr R. Combination of endoscopic retrograde cholangiopancreatography and endoscopic ultrasonography-guided biliary drainage in malignant hilar biliary obstruction. Dig Endosc 2019; 31 (Suppl. 01) 50-54
• 6 Oken MM, Creech RH, Tormey DC. et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5: 649-655
• 7 Moore KP, Wong F, Gines P. et al. The management of ascites in cirrhosis: report on the consensus conference of the International Ascites Club. Hepatology 2003; 38: 258-266
• 8 Isayama H, Hamada T, Yasuda I. et al. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc 2015; 27: 259-264
• 9 Khashab MA, Van der Merwe S, Kunda R. et al. Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Endosc Int Open 2016; 4: E487-496
• 10 Cotton PB, Eisen GM, Aabakken L. et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010; 71: 446-454
• 11 Bill JG, Darcy M, Fujii-Lau LL. et al. A comparison between endoscopic ultrasound-guided rendezvous and percutaneous biliary drainage after failed ERCP for malignant distal biliary obstruction. Endosc Int Open 2016; 4: E980-985
• 12 Sharaiha RZ, Kumta NA, Desai AP. et al. Endoscopic ultrasound-guided biliary drainage versus percutaneous transhepatic biliary drainage: predictors of successful outcome in patients who fail endoscopic retrograde cholangiopancreatography. Surg Endosc 2016; 30: 5500-5505
• 13 Mukai T, Yasuda I, Nakashima M. et al. Metallic stents are more efficacious than plastic stents in unresectable malignant hilar biliary strictures: a randomized controlled trial. J Hepatobiliary Pancreat Sci 2013; 20: 214-222
• 14 Sangchan A, Kongkasame W, Pugkhem A. et al. Efficacy of metal and plastic stents in unresectable complex hilar cholangiocarcinoma: a randomized controlled trial. Gastrointest Endosc 2012; 76: 93-99
• 15 Rerknimitr R, Kladcharoen N, Mahachai V. et al. Result of endoscopic biliary drainage in hilar cholangiocarcinoma. J Clin Gastroenterol 2004; 38: 518-523
• 16 Rerknimitr R, Kongkam P, Kullavanijaya P. Outcome of self-expandable metallic stents in low-grade versus advanced hilar obstruction. J Gastroenterol Hepatol 2008; 23: 1695-1701
• 17 Moole H, Dharmapuri S, Duvvuri A. et al. Endoscopic versus percutaneous biliary drainage in palliation of advanced malignant hilar obstruction: a meta-analysis and systematic review. Can J Gastroenterol Hepatol 2016; 2016: 4726078
• 18 Baars JE, Kaffes AJ, Saxena P. EUS-guided biliary drainage: a comprehensive review of the literature. Endosc Ultrasound 2018; 7: 4-9
• 19 Sharaiha RZ, Khan MA, Kamal F. et al. Efficacy and safety of EUS-guided biliary drainage in comparison with percutaneous biliary drainage when ERCP fails: a systematic review and meta-analysis. Gastrointest Endosc 2017; 85: 904-914
• 20 Takahashi E, Fukasawa M, Sato T. et al. Biliary drainage strategy of unresectable malignant hilar strictures by computed tomography volumetry. World J Gastroenterol 2015; 21: 4946-4953
• 21 Vienne A, Hobeika E, Gouya H. et al. Prediction of drainage effectiveness during endoscopic stenting of malignant hilar strictures: the role of liver volume assessment. Gastrointest Endosc 2010; 72: 728-735
• 22 Lee TH, Kim TH, Moon JH. et al. Bilateral versus unilateral placement of metal stents for inoperable high-grade malignant hilar biliary strictures: a multicenter, prospective, randomized study (with video). Gastrointest Endosc 2017; 86: 817-827
• 23 Inoue T, Ishii N, Kobayashi Y. et al. Simultaneous versus sequential side-by-side bilateral metal stent placement for malignant hilar biliary obstructions. Dig Dis Sci 2017; 62: 2542-2549