IDUS in CBD Stone Recurrence High Risk Patients

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265311
• Other study ID #: 20221307-2
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2021
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Shanghai Municipal Hospital of Traditional Chinese Medicine
• Contact: Hang Zhao, PhD
• Phone: 18621186288
• Email: drzhaohang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Choledocholithiasis
• Recurrence
• Ultrasonography

Intervention

Procedure:
• IDUS examination
for patients with high risks of bile duct stones recurrence using IDUS during ERCP

Locations

Country	Name	City	State
China	Shang General Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Municipal Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	need for stents	it's a Yes or No categorical variable to describe if stents were deployed during ERCP	4 weeks
Secondary	operation time	the time from tracheal intubation to the end of ERCP was recorded	intraoperative
Secondary	radiation time	radiation time of each patient was recorded	4 weeks
Secondary	hospitalization cost	hospitalization cost of each patient was recorded	8 weeks
Secondary	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
Secondary	White blood cell count	Routine blood test	12 weeks
Secondary	Red blood cell count	Routine blood test	12 weeks
Secondary	Platelet count	Routine blood test	12 weeks
Secondary	total bilirubin, direct bilirubin	Liver function test	12 weeks
Secondary	Liver function test (ALT, AST)		12 weeks
Secondary	albumin	Liver function test	12 weeks
Secondary	total protein	Liver function test	12 weeks
Secondary	Gamma-glutamyl transferase (GGT) test	Liver function test	12 weeks
Secondary	An alkaline phosphatase (ALP) test	Liver function	12 weeks
Secondary	whether have a resection of gallbladder checklist	whether the patient has a resection of gallbladder after ERCP	48 weeks