Accuracy of revised 2019 ASGE high-risk criteria for suspected choledocholithiasis: A prospective cohort multicenter study

Phase 3

Completed

• Conditions: High-risk patients for choledocholithiasis; Choledocholithiasis,; Endoscopic retrograde cholangiopancreatography,; Guideline,; Endosonography

• Registration Number: TCTR20210812001
• Lead Sponsor: Rajavithi Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-12
• Study Completion: 2023-11-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

The patients who have at least one of the following high-risk criteria for choledocholithiasis:
1. Common bile duct stone on the ultrasound or cross-sectional imaging
2. Total bilirubin >4 mg/dL and dilated common bile duct
3. Ascending cholangitis

Exclusion Criteria

1.A history of liver transplantation
2.An active liver disease, including primary sclerosing cholangitis
3.A history of biliary surgery
4.Suspicion of pancreaticobiliary malignancy
5.A previously placed endobiliary stent or sphincterotomy
6.A history of biliary stricture
7.Concomitant IHD stones
8.Decompensated cirrhosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The presence of choledocholithiasis At the end of intervention Confirmed by EUS, or ERCP

Secondary Outcome Measures

Name	Time	Method
The impact of laboratory trends At the end of intervention The presence of choledocholithiasis confirmed by EUS, or ERCP