Endoscopic Ultrasound-guided Rendezvous Versus Precut Papillotomy

NCT06010576 | Recruiting DMC

• 1 other identifier: 2021.720-T
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

Selective bile duct cannulation is the most important step in endoscopic retrograde cholangiopancreatography (ERCP) for treatment of benign and malignant pancreatobiliary diseases, but it may fail in up to 15% of cases. Precut papillotomy is an advanced ERCP cannulation technique recommended by guidelines for rescue of difficult biliary access, but it is not without limitations. Endoscopic ultrasound (EUS)-guided biliary drainage is a novel interventional EUS technique that has been increasingly performed after failed biliary access by advanced ERCP cannulation techniques.

Conditions

Bile Duct Diseases

Keywords

ERCP, EUS

Outcome Measures

Primary Outcomes (1)

• The first session technical success for biliary access by EUS-guided rendezvous technique and early precut papillotomy in patients with difficult biliary access during ERCP

  Technical success by EUS RV is defined as successful EUS-guided needle access of bile duct confirmed by bile aspiration and cholangiogram, advancement of guidewire into bile duct and out of papilla, and obtaining deep biliary cannulation by retrieving the rendezvous guidewire into duodenoscope or by cannulation alongside the rendezvous guidewire. Technical success by Early Precut Papillotomy is defined as successful bile duct access by 1 of the 3 acceptable precut techniques in achieving deep biliary cannulation, confirmed by bile aspiration and cholangiogram.

  Intra-procedure, during ERCP

Secondary Outcomes (3)

• Procedure-related serious adverse events in the EUS-guided rendezvous group and the early precut papillotomy group within 30 days of ERCP

  From day of procedure to Day 30 after procedure

• Procedure time to achieve biliary access by the assigned study biliary access technique

  Intra-procedure, during ERCP

• Need for rescue biliary drainage procedures in patients with failed biliary access by the assigned study technique, including crossover to the other study biliary access technique, need for PTBD by interventional radiology

  Intra-procedure (during ERCP) and 3 days post procedure

Study Arms (2)

EUS-guided rendezvous group (EUS RV group)

ACTIVE COMPARATOR

In the EUS RV group, a linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.

Procedure: EUS-guided rendezvous

Early precut papillotomy group (EPP group)

ACTIVE COMPARATOR

In the EPP group, the precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome

Procedure: Early precut papillotomy group

Interventions

EUS-guided rendezvous PROCEDURE

A linear array echoendoscope would be used to evaluate the common bile duct and left intrahepatic duct in order to identify the optimal route for biliary access by fine needle. Using a 19 gauge EUS needle, the dilated biliary tree will be accessed by either a transduodenal puncture to the common bile duct or a transgastric puncture to the left intrahepatic duct under direct EUS guidance. The optimal access route will be based on patient's anatomy after EUS assessment and left to the discretion of the investigator. Next, a guidewire would be advanced through the needle into the bile duct and out of the papillary orifice. The echoendoscope would then be exchanged to a duodenoscope for ERCP. The EUS rendezvous ERCP procedure will be completed by retrieving the rendezvous guidewire into the duodenoscope or by cannulation alongside the rendezvous guidewire to obtain biliary access.

EUS-guided rendezvous group (EUS RV group)

Early precut papillotomy group PROCEDURE

The precut papillotomy would be performed with 1 of the following acceptable techniques per the usual practice of the study investigator and institution: 1) conventional precut papillotomy by needle knife, 2) precut fistulotomy by needle knife, or 3) transpancreatic precut papillotomy by papillotome

Early precut papillotomy group (EPP group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 years or older undergoing ERCP with indication for bile duct cannulation
• Native major papilla
• Difficult bile duct cannulation, defined by the presence of 1 of the following: 1) unsuccessful bile duct cannulation within 10 cannulation attempts, 2) unsuccessful bile duct cannulation within 10 minutes spent in cannulation, or 3) 2 unintended pancreatic duct cannulation or opacification with contrast
• Written informed consent available

You may not qualify if:

• Unable to provide written informed consent
• Contraindications for endoscopy due to comorbidities
• Prior biliary sphincterotomy
• Surgically altered upper gastrointestinal anatomy or duodenal obstruction precluding a standard ERCP
• Uncorrectable coagulopathy (INR \> 1.5) and thrombocytopenia (platelet \< 50,000) by blood product transfusion
• Pregnant patients

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Tokyo University: collaborator
• Gifu University Graduate School of Medicine: collaborator

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Raymond Tang, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Sia

CONTACT

26370428; felixsia@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)