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Endoscopy
DOI: 10.1055/a-2721-6292
Original article

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

Authors

  • Vinay Dhir

    1   Department of Gastroenterology, Institute of Digestive and Liver Care, SL Raheja Hospital (a Fortis Associate), Mumbai, India

  • Vivek Kumar Singh

    1   Department of Gastroenterology, Institute of Digestive and Liver Care, SL Raheja Hospital (a Fortis Associate), Mumbai, India

  • Sundeep Lakhtakia 

    2   Department of Gastroenterology, AIG Hospitals, Hyderabad, India

  • Rajesh Puri

    3   Department of Gastroenterology, Institute of Gastrosciences, Medanta Hospital, Gurugram, India

  • Praveer Rai

    4   Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India

  • Nonthalee Pausawasdi

    5   Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand

  • Ryosuke Tonozuka 

    6   Department of Gastroenterology, Tokyo Medical University, Tokyo, Japan

  • Jahangeer Basha 

    2   Department of Gastroenterology, AIG Hospitals, Hyderabad, India

  • Varayu Prachayakul

    5   Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand

  • Abhishek Kathuria

    3   Department of Gastroenterology, Institute of Gastrosciences, Medanta Hospital, Gurugram, India

  • Pankaj Kumar 

    4   Department of Gastroenterology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India

  • Takao Itoi

    6   Department of Gastroenterology, Tokyo Medical University, Tokyo, Japan

  • D. Nageshwar Reddy

    2   Department of Gastroenterology, AIG Hospitals, Hyderabad, India

Supported by: Asian endoscopy research foundation, Hongkong

Clinical Trial:

Registration number (trial ID): CTRI/2021/10/037018, Trial registry: Clinical Trials Registry India (http://www.ctri.nic.in/Clinicaltrials), Type of Study: Prospective, Randomized, Multi-Center Study


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Graphical Abstract

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.

Supplementary Material



Publication History

Received: 31 March 2025

Accepted after revision: 12 October 2025

Accepted Manuscript online:
12 October 2025

Article published online:
15 December 2025

© 2025. Thieme. All rights reserved.

Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany

 

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