IDUS in CBD Stone Recurrence High Risk Patients

Last updated: April 17, 2024
Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gall Bladder Disorders

Treatment

IDUS examination

Clinical Study ID

NCT06265311
20221307-2
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

    1. Clinical diagnosis of liver or biliary malignant tumor. 2. Clinical diagnosis ofduodenal malignant tumor 3. Failure or unexpected termination of ERCP 4. Surgeryhistory of gallbladder or bile duct.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: IDUS examination
Phase:
Study Start date:
November 02, 2021
Estimated Completion Date:
June 30, 2024

Study 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.

Connect with a study center

  • Shang General Hospital

    Shanghai, 200080
    China

    Active - Recruiting

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