IDUS in CBD Stone Recurrence High Risk Patients

NCT06265311 | Completed

• 1 other identifier: 20221307-2
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP. Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy. Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded. Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.

Conditions

Choledocholithiasis; Cholangiopancreatography, Endoscopic Retrograde; Ultrasonography

Keywords

Choledocholithiasis; Cholangiopancreatography, Endoscopic Retrograde; Ultrasonography; Bile Ducts

Outcome Measures

Primary Outcomes (3)

• recurrence of bile duct stone or cholangitis

  patients will be followed up for 48 weeks to record the recurrence of CBD stones or cholangitis

  48 weeks

• need for a nasobiliary tube

  it's a Yes or No categorical variable to describe if the patient was placed a nasobiliary tube during ERCP

  2 weeks

• need for stents

  it's a Yes or No categorical variable to describe if stents were deployed during ERCP

  4 weeks

Secondary Outcomes (14)

• operation time

  intraoperative

• radiation time

  4 weeks

• hospitalization cost

  8 weeks

• Questionnaire of Symptoms and conditions after ERCP

  8 weeks

• White blood cell count

  12 weeks

Study Arms (2)

IDUS examination during ERCP

EXPERIMENTAL

CBD stones cases with high recurrence risks apply IDUS during ERCP

Procedure: IDUS examination

Control

NO INTERVENTION

CBD stones cases with high recurrence risks don't apply IDUS during ERCP

Interventions

IDUS examination PROCEDURE

for patients with high risks of bile duct stones recurrence using IDUS during ERCP

IDUS examination during ERCP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of common bile duct stones 2.At least one of the following, diameter of CBD\>1.5cm, or number of calculi\>2, or lithotripsy during ercp

You may not qualify if:

• \. Clinical diagnosis of liver or biliary malignant tumor. 2. Clinical diagnosis of duodenal malignant tumor 3. Failure or unexpected termination of ERCP 4. Surgery history of gallbladder or bile duct.

Sponsors & Collaborators

• Shanghai Municipal Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Shang General Hospital

Shanghai, 200080, China

Location

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hang Zhao, PhD

  Shanghai Municipal Traditional Chinese Medicine Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: February 20, 2024
• Study Start: November 2, 2021
• Primary Completion: January 31, 2024
• Study Completion: April 16, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)