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NCT03482375 · ClinicalTrials.gov registry record
Prospective Evaluation of Residual Bile Duct Stone by Peroral Cholangioscopy After Conventional ERCP
A clinical trial, sponsored by Northwell Health.
- Completed
- Registry status
- 140
- Enrollment target
NCT03482375: Completed study, sponsored by Northwell Health.
NCT03482375 is a clinical trial that has completed, run by Northwell Health. The registered enrollment target is 140 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03482375 has completed, sponsored by Northwell Health.
- COMPLETED
- Registry status
- 140 participants
- Enrollment target
Study 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.
Primary Outcome
The primary outcome of this study is to assess if digital peroral cholangioscopy (POC) will enhance the diagnostic yield in the detection of residual biliary stones that are missed during conventional ERCP. The primary outcome will be assessed at the time of the procedure (i.e. residual stone seen with POC vs. no residual stone seen with POC). We will enroll approximately 100 patients over a 2-year period. At study completion, the primary outcome measure for all patients will be analyzed and dat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-12-17 |
| Est. Completion | 2019-02-10 |
What the finished NCT03482375 record still lists
NCT03482375 is an observational study that tracks outcomes without assigning an intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03482375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03482375 about?
NCT03482375 is a clinical study titled "Prospective Evaluation of Residual Bile Duct Stone by Peroral Cholangioscopy After Conventional ERCP". 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...
What is the current status of trial NCT03482375?
This trial is currently completed. The enrollment target is 140 participants. The study started on 2015-12-17. Estimated completion is 2019-02-10.
Who is sponsoring clinical trial NCT03482375?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
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