Role of EUS in High Risk of Choledocholithiasis

Not Applicable

Completed

• Conditions: Choledocholithiasis
• Interventions: Device: EUS; Device: ERCP

• Registration Number: NCT03250286
• Lead Sponsor: Woo Hyun Paik

Brief Summary

The aim of this study is to demonstrate that patients with high risk of choledocholithiasis who undergo ERCP only for patients with choledocholith in the EUS examination\[EUS-ERCP group\] have less negative outcomes (including false-negative results and procedure-related complications) than patients who undergo ERCP in all patients with high risk of choledocholithiasis\[ERCP group\]. The primary outcome is the incidence of negative outcomes (including false-negative results and procedure-related complications) in both groups. The secondary outcomes included days of hospitalization and the rate of diagnostic ERC.

Detailed Description

Several studies have shown that EUS testing prior to ERCP may reduce ERCP complications in patients with intermediate-risk choledocholithiasis. In other words, this results obtained by not performing ERCP in patients without choledocholith in the EUS examination. However, to the best of our knowledge, no prospective study has been conducted on the role of EUS in patients with high risk of choledocholithiasis. Therefore, we investigate the role of EUS screening in patients with high risk of choledocholithiasis. We compare the negative outcomes (including false negative and procedure-related complications of EUS and ERCP) of the 'EUS-ERCP group' in which ERCP is performed when necessary after the EUS examination and the 'ERCP group' in which ERCP is performed in all patients.

Study Timeline

• Study First Submitted: 2017-07-18
• Study Start: 2017-07-25
• Study First Submitted QC: 2017-08-14
• Study First Posted: 2017-08-15
• Primary Completion: 2020-06-05
• Study Completion: 2020-06-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Abdominal CT or US showed a common bile duct diameter > 6mm (>8mm in patients with previous cholecystectomy) and elevated total bilirubin from 1.8mg/dL to less than 4.0mg/dL

Exclusion Criteria

• Severe mental illness
• Severe co-morbidity (ESRD, Advanced COPD, severe Heart failure, poorly controlled blood sugar)
• Pregnancy
• Pancreatic cancer or suspected malignant tumor of the biliary tract
• Acute pancreatitis
• Patient who has confirmed biliary stones in abdominal ultrasonography or CT
• Severe cholangitis according to TG 18 guideline
• Total bilirubin > 4mg/dL
• Patients who have difficulty with EUS or ERCP due to previous gastric surgery (Billroth II or TG with R-en-Y)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS-ERCP group	EUS	EUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.
ERCP group	ERCP	ERCP without EUS is performed in all patients.
EUS-ERCP group	ERCP	EUS is performed first, and when the examiner finds bile duct stone in the EUS examination, ERCP is performed to remove the stone.

Primary Outcome Measures

Name	Time	Method
Any negative outcomes related to either a false-negative diagnosis of choledocholithiasis or the endoscopic procedure	6 months after randomization	Negative outcomes associated with a false-negative diagnosis of choledocholithiasis were defined as follows: 1) diagnosis of choledocholithiasis during follow-up or 2) hospitalization for a condition likely associated with choledocholithiasis, such as biliary pancreatitis, cholangitis, or obstructive jaundice. Negative outcomes of endoscopic procedures were assessed according to the ASGE lexicon

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	6 months after randomization	Length of hospital stay

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of