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

Status: Completed
Location: See all (2) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient receiving ERCP as standard of care for suspected or documented choledocholithiasis as assessed by one or more of the following:

‣ Abnormal imaging on ultrasound, endoscopic ultrasound (EUS), CT scan, or MRCP suggestive of choledocholithiasis

⁃ Clinical signs and symptoms suggestive of choledocholithiasis such as jaundice, abdominal pain, pruritis, pancreatitis, and/or cholangitis

⁃ Abnormal liver function tests suggestive of choledocholithiasis (eg: serum bilirubin \> 1.5 and/or elevated alkaline phosphatase levels)

• In addition to one or more of the above inclusion criteria, patient must also satisfy one or more of the following:

‣ Mechanical lithotripsy, electrohydraulic lithotripsy, or laser lithotripsy performed for therapy of bile duct stones.

⁃ Bile duct \> 12mm on prior tests (any portion of duct)

⁃ History of recurrent abnormal LFTs with negative cholangiogram.

⁃ Positive EUS or MRCP for biliary stones with a negative cholangiogram

Locations
United States
New York
North Shore University Hospital
Manhasset
LIJ Medical Center- NSLIJ Health System
New Hyde Park
Time Frame
Start Date: 2015-12-17
Completion Date: 2019-02-10
Participants
Target number of participants: 140
Treatments
No Stones on POC after ERCP
This is a cohort in which there are no stones seen on Cholangioscopy after ERCP and cholangiogram to treat gall stones.
Stones seen on POC after ERCP
This is a cohort in which there are no stones seen on Cholangioscopy after ERCP and cholangiogram to treat gall stones.
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Northwell Health

This content was sourced from clinicaltrials.gov