CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
EUS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03250286
NCT03250286N/ACompleted

Role of EUS in High Risk of Choledocholithiasis

Woo Hyun Paik·interventional·Posted Aug 15, 2017·Updated Mar 18, 2021

In Brief

A clinical study evaluating EUS and ERCP for Choledocholithiasis. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 15, 2017
Enrollment StartJul 25, 2017
Primary CompletionJun 5, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.9 years ago

Interventions

EUSdevice

Endoscopic ultrasound (EUS) is performed with radial scanning echo endoscope (Olympus GF UE260) by four endosonographers. EUS examination is performed first, and if there is choledocholith, ERCP is performed.

ERCPdevice

Endoscopic retrograde cholangiopancreatography (ERCP) is performed with duodenoscope (Olympus JF-260V or TJF-260V) by four endoscopists. * In the EUS-ERCP group, ERCP is used to remove bile duct stones diagnosed via EUS. Therefore, only ERCP is performed in patients with choledocholithiasis in EUS. * In the ERCP group, diagnosis and treatment of bile duct stones are performed with ERCP.