EUS Guided ERCP in Bile Duct Stone Removal

NCT02870686 | Completed DMC

• 1 other identifier: EC: 56-199-21-3-2
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

For endoscopist, ERCP for bile duct stone removal is the most widely performed procedure. However, the risk associated radiation exposure to patients and staff are not neglible. Earlier studies, ERCP without the use of fluoroscopy has been reported high success for bile duct stone removal in pregnant patients to prevent radiation exposure to the fetus. EUS is highy accurate technique in detecting common bile duct stone and guiding for therapeutic intervention. There has been a few data from literature showed that EUS guided CBD stone ( CBDS ) removal are equivalent to those following ERCP in term of successful CBDS removal and complications. This randomized trial is designed to address the question that EUS guided CBDS removal is equivalent to ERCP in term of efficacy and safety.

Conditions

Choledocholithiasis

Keywords

ERCP; EUS guided ERCP without fluoroscopy

Outcome Measures

Primary Outcomes (1)

• Treatment success

  The number of patients who achieved complete stone clearance in either EGWF or ERCP techniques.

  24 months

Secondary Outcomes (1)

• Technical success

  24 hours

Other Outcomes (3)

• Compare procedure time

  24 hours

• Compare fluoroscopy time

  24 hours

• Complication rate

  30 days

Study Arms (2)

ERCP without the use of fluoroscopy

ACTIVE COMPARATOR

Patients with uncomplicated bile duct stones detected by EUS was assigned to the EUS guided ERCP without fluoroscopy clear all of the bile duct stones.

Procedure: ERCP without the use of fluoroscopy

ERCP with the use of fluoroscopy

ACTIVE COMPARATOR

Patients with uncomplicated bile duct stones detected by EUS was assigned to underwent ERCP with the use of fluoroscopy to clear all of the bile duct stones.

Procedure: ERCP with the use of fluoroscopy

Interventions

ERCP without the use of fluoroscopy PROCEDURE

ERCP removal of stone technique without the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with catheter aspiration of bile, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket- number of stones removed should compare number detected on EUS, (5) confirmation of complete stone clearance with radiocontrast.

ERCP without the use of fluoroscopy

ERCP with the use of fluoroscopy PROCEDURE

ERCP removal of stone technique with the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with fluoroscopy images, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket, (5) confirmation of complete stone clearance with radiocontrast.

ERCP with the use of fluoroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who had EUS presence of CBDS ≤ 10 mm, and EUS images absence of CBD stricture and CBD narrowing below the stones

You may not qualify if:

• pregnancy
• concomitant intrahepatic bile duct stones
• malignant bile duct stricture
• altered gastrointestinal anatomy
• instability hemodynamics
• concomitant emergency situation
• unwilling to participate

Sponsors & Collaborators

• Prince of Songkla University: lead

Study Sites (1)

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (1)

• Netinatsunton N, Sottisuporn J, Attasaranya S, Witeerungrot T, Siripun A, Pattarapuntakul T, Ovartlarnporn B. Prospective randomized trial of EUS-assisted ERCP without fluoroscopy versus ERCP in common bile duct stones. Gastrointest Endosc. 2017 Dec;86(6):1059-1065. doi: 10.1016/j.gie.2017.03.1539. Epub 2017 Apr 7.

  PMID: 28392365 DERIVED

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Nisa Netinatsunton, MD.

  NKC Institute of Gastroenterology and Hepatology , Faculty of Medicine, Prince of Songkla University.

  PRINCIPAL INVESTIGATOR

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: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2016
• First Posted: August 17, 2016
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 14, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)