Endoscopic ultrasound-guided transpapillary versus transluminal biliary stenting: randomized comparison of long-term stent patency

Abstract

Background

Endoscopic ultrasound-guided biliary drainage (EUS-BD) may be transluminal (choledochoduodenostomy [CDS] and hepaticogastrostomy [HGS]) or transpapillary via an antegrade approach; it is unclear which route is preferred. We conducted a multicenter randomized study comparing the two routes.

Methods

In this open-label randomized study from five tertiary centers, patients with unresectable malignant biliary obstruction and failed endoscopic retrograde cholangiopancreatography were randomized to either EUS-CDS/HGS or transpapillary stenting. The primary outcome was stent patency (recurrent biliary obstruction), assessed at 1, 3, 6, and 12 months. Analysis was on a per-protocol basis.

Results

120 patients (67 males) were recruited (November 2021 to March 2024), with 60 patients in each arm (24 CDS, 36 HGS). The median time to recurrent biliary obstruction was 294 days (95%CI 257.95–330.04) in the transpapillary group and 219 days (95%CI 122.45–315.54) in the transluminal group (P = 0.03). At 3 months, 11/54 stents (20.4%) were blocked in the transluminal group versus 3/52 (5.8%) in the transpapillary group (odds ratio [OR] 0.24, 95%CI 0.06–0.91; P = 0.04). At 6 months, 21/54 stents (38.9%) were blocked in the transluminal group versus 11/52 (21.2%) in the transpapillary group (OR 0.42, 95%CI 0.18–0.99; P = 0.04). There were 13 (21.7%) adverse events in the transluminal group (one death), and 8 (13.3%) in the transpapillary group (OR 0.57, 95%CI 0.21–1.46; P = 0.33).

Conclusion

Transpapillary EUS-BD achieved longer stent patency and a lower rate of recurrent biliary obstruction at 3 and 6 months compared with the transluminal route.

• References

• 1 Dhir V, Shah R, Udawat P. Endoscopic ultrasound-guided biliary interventions. Gastrointest Endosc Clin N Am 2022; 32: 507-525
• 2 Dhir V, Isayama H, Itoi T. et al. Endoscopic ultrasonography-guided biliary and pancreatic duct interventions. Dig Endosc 2017; 29: 472-485
• 3 Paik WH, Lee TH, Park DH. et al. EUS-guided biliary drainage versus ERCP for the primary palliation of malignant biliary obstruction: a multicenter randomized clinical trial. Am J Gastroenterol 2018; 113: 987-997
• 4 Barbosa EC, do Espírito Santo PA, Baraldo S. et al. EUS versus ERCP-guided biliary drainage for malignant biliary obstruction: a systematic review and meta-analysis of randomized controlled trials. Gastrointest Endosc 2024; 100: 395-405.e8
• 5 Khoury T, Sbeit W, Lisotti A. et al. Endoscopic ultrasound versus ERCP-guided primary drainage of inoperable malignant distal biliary obstruction: systematic review and meta-analysis of randomized controlled trials. Endoscopy 2024; 56: 955-963
• 6 Gopakumar H, Singh RR, Revanur V. et al. Endoscopic ultrasound-guided vs endoscopic retrograde cholangiopancreatography-guided biliary drainage as primary approach to malignant distal biliary obstruction: a systematic review and meta-analysis of randomized controlled trials. Am J Gastroenterol 2022; 12: 1607-1615
• 7 Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother 2010; 1: 100-107
• 8 Isayama H, Hamada T, Yasuda I. et al. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc 2015; 27: 259-264
• 9 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
• 10 Loew BJ, Howell DA, Sanders MK. et al. Comparative performance of uncoated, self-expanding metal biliary stents of different designs in 2 diameters: final results of an international multicenter, randomized, controlled trial. Gastrointest Endosc 2009; 70: 445-453
• 11 Ghazi R, AbiMansour JP, Mahmoud T. et al. Uncovered versus fully covered self-expandable metal stents for the management of distal malignant biliary obstruction. Gastrointest Endosc 2023; 98: 577-584
• 12 Saleem A, Leggett CL, Murad MH. et al. Meta-analysis of randomized trials comparing the patency of covered and uncovered self-expandable metal stents for palliation of distal malignant bile duct obstruction. Gastrointest Endosc 2011; 74: 321-327
• 13 Chen YI, Sahai A, Donatelli G. et al. Endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs endoscopic retrograde cholangiopancreatography in malignant distal biliary obstruction: a multicenter randomized controlled study (ELEMENT trial). Gastroenterology 2023; 165: 1249-1261
• 14 Teoh AY, Napoleon B, Kunda R. et al. EUS-guided choledocho-duodenostomy using lumen apposing stent versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction: a multicenter randomized controlled trial (DRA-MBO Trial). Gastroenterology 2023; 165: 473-482
• 15 Fritzsche JA, Fockens P, Besselink MG. et al. Endoscopic ultrasound-guided choledochoduodenostomy using single-step lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-p): a prospective pilot study. Endoscopy 2024; 56: 47-52
• 16 Fritzsche JA, Fockens P, Besselink MG. et al. Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study. Gastrointest Endosc 2025; 101: 1009-1016
• 17 Amato A, Sinagra E, Celsa C. et al. Efficacy of lumen-apposing metal stents or self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy: a systematic review and meta-analysis. Endoscopy 2021; 53: 1037-1047
• 18 Vanella G, Bronswijk M, Dell’Anna G. et al. Classification, risk factors, and management of lumen apposing metal stent dysfunction during follow-up of endoscopic ultrasound-guided choledochoduodenostomy: multicenter evaluation from the Leuven-Amsterdam-Milan Study Group. Dig Endosc 2023; 35: 377-388
• 19 Ishiwatari H, Ogura T, Hijioka S. et al. EUS-guided hepaticogastrostomy versus EUS-guided hepaticogastrostomy with antegrade stent placement in patients with unresectable malignant distal biliary obstruction: a propensity score–matched case-control study. Gastrointest Endosc 2024; 100: 66-75
• 20 Paraskevopoulos P, Obeidat M, Bednárik D. et al. Hepaticogastrostomy versus hepaticogastrostomy with antegrade stenting for malignant biliary obstruction: a systematic review and meta-analysis. Therap Adv Gastroenterol 2024; 17: 17562848241273085
• 21 Shen Y, Lv Y, Zheng X. et al. Comparison between endoscopic ultrasound-guided antegrade and transluminal stent implantation in distal malignant biliary obstruction after failed ERCP. Gastroenterol Res Pract 2024; 2024: 1458297
• 22 Zhao X, Shi L, Wang J. et al. Clinical value of preferred endoscopic ultrasound-guided antegrade surgery in the treatment of extrahepatic bile duct malignant obstruction. Clinics (Sao Paulo) 2022; 77: 100017
• 23 Yamada M, Hara K, Haba S. et al. Hepatobiliary scintigraphy of bile excretion after endoscopic ultrasound-guided hepaticogastrostomy for malignant biliary obstruction: a retrospective study in Japan. Clin Endosc 2024; 57: 798
• 24 Abraham H, Thomas S, Srivastava A. Sump syndrome: a rare long-term complication of choledochoduodenostomy. Case Rep Gastroenterol 2017; 11: 428-433
• 25 de Benito Sanz M, Nájera-Muñoz R, de la Serna-Higuera C. et al. Lumen apposing metal stents versus tubular self-expandable metal stents for endoscopic ultrasound-guided choledochoduodenostomy in malignant biliary obstruction. Surg Endosc 2021; 35: 6754-6762
• 26 Garcia-Sumalla A, Loras C, Guarner-Argente C. et al. Is a coaxial plastic stent within a lumen-apposing metal stent useful for the management of distal malignant biliary obstruction?. Surg Endosc 2021; 35: 4873-4881
• 27 Cho SH, Kim SJ, Song TJ. et al. Comparison of fully versus partially covered metal stents in endoscopic ultrasound-guided hepaticogastrostomy for malignant biliary obstruction (with video). Dig Endosc 2025; 37: 532-540