IDUS in CBD Stone Recurrence High Risk Patients

Practical Value of IDUS in Patients With High Risk of Recurrence of Common Bile Duct Stones After ERCP Lithotomy

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.

Study Overview

• Status: Completed
• Conditions: Ultrasonography; Choledocholithiasis; Cholangiopancreatography, Endoscopic Retrograde
• Intervention / Treatment: Procedure: IDUS examination

Detailed Description

Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.

High risks were defined as diameter of CBD>1.5cm, number of calculi>2, and lithotripsy.

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.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200080
    • Shang General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1.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

Exclusion Criteria:

• 1. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDUS examination during ERCP; CBD stones cases with high recurrence risks apply IDUS during ERCP	Procedure: IDUS examination; for patients with high risks of bile duct stones recurrence using IDUS during ERCP
No Intervention: Control; CBD stones cases with high recurrence risks don't apply IDUS during ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	the time from tracheal intubation to the end of ERCP was recorded	intraoperative
radiation time	radiation time of each patient was recorded	4 weeks
hospitalization cost	hospitalization cost of each patient was recorded	8 weeks
Questionnaire of Symptoms and conditions after ERCP	Questionnaire of symptoms and conditions after ERCP were recorded. Degree of abdominal pain and distension were recorded with a highest level of three points respectively.	8 weeks
White blood cell count	Routine blood test	12 weeks
Red blood cell count	Routine blood test	12 weeks
Platelet count	Routine blood test	12 weeks
total bilirubin, direct bilirubin	Liver function test	12 weeks
Liver function test (ALT, AST)		12 weeks
albumin	Liver function test	12 weeks
total protein	Liver function test	12 weeks
Gamma-glutamyl transferase (GGT) test	Liver function test	12 weeks
An alkaline phosphatase (ALP) test	Liver function	12 weeks
whether have a resection of gallbladder checklist	whether the patient has a resection of gallbladder after ERCP	48 weeks

Collaborators and Investigators

• Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
• Collaborators: Shanghai University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Hang Zhao, PhD, Shanghai Municipal Traditional Chinese Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): April 16, 2026

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: February 16, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasonography; Choledocholithiasis; Cholangiopancreatography, Endoscopic Retrograde; Bile Ducts
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholelithiasis; Common Bile Duct Diseases; Choledocholithiasis
• Other Study ID Numbers: 20221307-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No