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IDUS in CBD Stone Recurrence High Risk Patients

S

Shanghai Municipal Hospital of Traditional Chinese Medicine

Status

Enrolling

Conditions

Cholangiopancreatography, Endoscopic Retrograde
Ultrasonography
Choledocholithiasis

Treatments

Procedure: IDUS examination

Study type

Interventional

Funder types

Other

Identifiers

NCT06265311
20221307-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

IDUS examination during ERCP
Experimental group
Description:
CBD stones cases with high recurrence risks apply IDUS during ERCP
Treatment:
Procedure: IDUS examination
Control
No Intervention group
Description:
CBD stones cases with high recurrence risks don't apply IDUS during ERCP

Trial contacts and locations

1

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Central trial contact

Hang Zhao, PhD

Data sourced from clinicaltrials.gov

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