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

Endoscopic ultrasound-guided trans-papillary versus trans-luminal biliary stenting: Randomized comparison of long term stent patency

Authors

  • Vinay Dhir

    1   Department of gastroenterology, Institute of disgetive and liver care, S. L. Raheja hospital, Mumbai, India

  • Vivek Kumar Singh

    2   Endoscopy, Institute of digestive and liver care, S. L. Raheja hospital, Mumbai, India

  • Sundeep Lakhtakia 

    3   Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India

  • Rajesh Puri

    4   Institute of Digestive & Hepatobiliary Sciences, Medanta The Medicity, Gurgaon, India
    4   Institute of Digestive & Hepatobiliary Sciences, Medanta The Medicity, Gurgaon, India

  • Praveer Rai

    5   Gastroenterology, SGPGI, Lucknow, India

  • Nonthalee Pausawasdi

    6   Internal medicine, Mahidol University Faculty of Medicine Siriraj Hospital, Bangkok, Thailand (Ringgold ID: RIN65106)

  • Ryosuke Tonozuka 

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

  • Basha Jahangeer 

    8   Gastroenterology, Asian Institute of Gastroenterology, Hyderabad, India (Ringgold ID: RIN78470)

  • Varayu Prachayakul

    9   gastroenterology, internal medicine, siriraj hospital, Bangkok, Thailand

  • Abhishek Kathuria

    10   GASTROENTEROLOGY, MEDANTA, Gurgaon, India

  • Pankaj Kumar 

    5   Gastroenterology, SGPGI, Lucknow, India

  • Takao Itoi

    11   Gastroenterology, Tokyo Medical University, Shinjuku-ku, Japan (Ringgold ID: RIN13112)

  • Nageshwar D. Reddy

    3   Gastroenterology, Asian Institute of Gastroenterology, 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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Background and study aims: The two routes of EUS-guided biliary drainage(EUS-BD) are trans-luminal(TL) (choledocho-duodenostomy(CDS) and hepatico-gastrostomy(HGS)) and trans-papillary(TP) via an antegrade approach(AG). It is unclear whether TP or TL drainage should be preferred. We conducted a multicenter randomized study to compare the two routes. Patients and Methods: In this open label randomized study from 5 tertiary care centers, patients with unresectable malignant biliary obstruction and failed ERCP were randomized into receiving either EUS-guided transluminal (CDS or HGS) or transpapillary stenting (AG). Primary outcome was stent patency (recurrent biliary obstruction), assessed at 1,3,6, and 12 months. Analysis was done on per protocol basis. Results: 120 patients (67 males) were recruited from November 2021 to March 2024. There were 60 patients each in the TL (24CDS,36HGS) and TP arm. Median time to recurrent biliary obstruction was 294 days (95%CI 257.95 – 330.04) for TP group and 219 days (95% CI 122.45- 315.54) for TL group (p=0.03). At three months, 11 stents (20.37%) blocked in the TL group compared to three (5.77%) in the TP group (OR=0.24, 0.06-0.91, p=0.04). At six months, 21 (38.89%) stents blocked in the TL arm compared to 11 (21.15%) in the TP arm (OR=0.42, 0.17-0.99. P=0.04). There were 13 (21.66%) adverse events in the TL group (one death), and 8 (13.33%) in the TP group (OR=0.57,0.21-1.46. P=0.33). Conclusion: EUS-BD via TP route achieved longer stent patency and lower rate of recurrent biliary obstruction at 3 and 6 months compared to TL route.



Publication History

Received: 31 March 2025

Accepted after revision: 12 October 2025

Accepted Manuscript online:
12 October 2025

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