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Endoscopy
DOI: 10.1055/a-2515-1712
Original article

Randomized comparison of precut papillotomy versus an endoscopic ultrasound-guided rendezvous procedure for difficult biliary access in malignant distal biliary obstruction

Vinay Dhir
1   Endoscopy, Institute of Digestive and Liver Care, SL Raheja Hospital, Mumbai, India (Ringgold ID: RIN81542)
,
Vivek Kumar Singh
1   Endoscopy, Institute of Digestive and Liver Care, SL Raheja Hospital, Mumbai, India (Ringgold ID: RIN81542)
,
Ankit Dalal 
2   Endoscopy, Institute of Gastrosciences, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai, India (Ringgold ID: RIN81727)
,
Gaurav Kumar Patil
2   Endoscopy, Institute of Gastrosciences, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai, India (Ringgold ID: RIN81727)
,
Amit Maydeo 
2   Endoscopy, Institute of Gastrosciences, Sir HN Reliance Foundation Hospital and Research Centre, Mumbai, India (Ringgold ID: RIN81727)
› Author Affiliations Clinical Trial: Registration number (trial ID): CTRI/2012/12/003248, Trial registry: Clinical Trials Registry India (http://www.ctri.nic.in/Clinicaltrials), Type of Study: Randomized
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Abstract

Background

Difficult biliary cannulation (DBC) is a marker for prolonged procedure time and a higher rate of adverse events (AEs) during endoscopic retrograde cholangiopancreatography (ERCP). We previously showed that endoscopic ultrasound-assisted rendezvous (EUS-RV) procedures had a higher single-session success rate than precut papillotomy (PCP) in cases of DBC. The present randomized study aimed to compare the technical success and AE rates of the two approaches

Methods

This was an open-label randomized controlled trial in a tertiary care setting. Patients with malignant distal biliary obstruction (MDBO) and DBC were enrolled. The patients were randomized to PCP with a needle-knife or EUS-RV. The primary outcome was technical success; secondary outcomes were the AE rate, procedure duration, and length of hospital stay (LOS).

Results

208 patients were enrolled, 104 in each group. There were no statistically significant differences in technical success (93.3% PCP vs. 97.1% EUS-RV; P = 0.33; odds ratio [OR] 0.4, 95%CI 0.1–1.6) and overall AE rate (11.5% PCP vs. 5.8% EUS-RV; P=0.14; OR 0.5, 95%CI 0.8–5.9). Pancreatitis was higher in the PCP group (8.7% vs. 1.9%; P=0.06; OR 4.8, 95%CI 1.0–22.9). The mean duration of the procedure was significantly higher for EUS-RV (47 vs. 27 minutes; P<0.001). LOS was similar in the two groups (1.2 PCP vs. 1.1 days EUS-RV; P=0.25).

Conclusion

Both PCP and EUS-RV have comparable rates of success, AEs, mortality, and LOS. EUS-RV could be used as an alternative to PCP in patients with MDBO and DBC.

Supplementary Material



Publication History

Received: 10 September 2024

Accepted after revision: 12 January 2025

Accepted Manuscript online:
12 January 2025

Article published online:
07 February 2025

© 2025. Thieme. All rights reserved.

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

 

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