Skip to main content
OpenTrials
Completed

NCT Number: NCT06265311

IDUS in CBD Stone Recurrence High Risk Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Choledocholithiasis Bile Duct Diseases Biliary Tract Diseases Cholangiopancreatography, Endoscopic Retrograde Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Ultrasonography

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shang General Hospital

Shanghai, 200080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IDUS examination

Procedure

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

Primary outcomes

  1. recurrence of bile duct stone or cholangitis

    Time frame: 48 weeks

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

  2. need for a nasobiliary tube

    Time frame: 2 weeks

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

  3. need for stents

    Time frame: 4 weeks

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

Secondary outcomes

  1. operation time

    Time frame: intraoperative

    the time from tracheal intubation to the end of ERCP was recorded

  2. radiation time

    Time frame: 4 weeks

    radiation time of each patient was recorded

  3. hospitalization cost

    Time frame: 8 weeks

    hospitalization cost of each patient was recorded

  4. Questionnaire of Symptoms and conditions after ERCP

    Time frame: 8 weeks

    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.

  5. White blood cell count

    Time frame: 12 weeks

    Routine blood test

  6. Red blood cell count

    Time frame: 12 weeks

    Routine blood test

  7. Platelet count

    Time frame: 12 weeks

    Routine blood test

  8. total bilirubin, direct bilirubin

    Time frame: 12 weeks

    Liver function test

  9. Liver function test (ALT, AST)

    Time frame: 12 weeks

  10. albumin

    Time frame: 12 weeks

    Liver function test

  11. total protein

    Time frame: 12 weeks

    Liver function test

  12. Gamma-glutamyl transferase (GGT) test

    Time frame: 12 weeks

    Liver function test

  13. An alkaline phosphatase (ALP) test

    Time frame: 12 weeks

    Liver function

  14. whether have a resection of gallbladder checklist

    Time frame: 48 weeks

    whether the patient has a resection of gallbladder after ERCP

Sponsors and collaborators

Lead sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.