CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03482375
NCT03482375N/ACompleted

Prospective Evaluation of Residual Bile Duct Stone Detection by Peroral Cholangioscopy That Is Missed With Conventional ERCP and Cholangiogram

Northwell Health·observational·Posted Mar 29, 2018·Updated Feb 19, 2019

In Brief

An observational study for Gall Stones. Completed, enrolled 140 participants across 2 sites.

Detailed Summary

Gallstone disease affects over 20 million Americans. Among patients with gallbladder disease, the prevalence of choledocholithiasis (stones in the bile duct) is estimated to be 10-20%. Endoscopic retrograde cholangiopancreatography (ERCP) is considered the standard of care for removing stones in the bile duct utilizing a variety of conventional methods including biliary sphincterotomy, sphincteroplasty, extraction balloon, retrieval basket, and mechanical lithotripsy. After removal of stones from the bile duct, an occlusion cholangiogram is usually performed to confirm complete bile duct clearance. However, cholangiogram can miss residual stones in 11- 30% of cases - especially in the setting of a dilated bile duct, large stones, severe pneumobilia, juxtapapillary diverticulum, primary sclerosing cholangitis, and after lithotripsy (mechanical, electrohydraulic, or laser). The approach to patients with choledocholithiasis requires careful attention because missed bile duct stones can cause recurrent biliary symptoms, pancreatitis, cholangitis, and has significant cost implication with the need for repeat imaging and/or procedures.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsGall Stones
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 29, 2018
Enrollment StartDec 17, 2015
Primary CompletionOct 30, 2018
Study CompletionFeb 10, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 8.3 years ago