Prospective Evaluation of Residual Bile Duct Stone by Peroral Cholangioscopy After Conventional ERCP

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Description

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 Start Date

December, 17 2015

Estimated Completion Date

July 2018

Interventions

No interventions cited

Study ID

Northwell Health -- HS15-0674

Status

Recruiting

Trial ID

NCT03482375

Study Type

Observational [Patient Registry]

Trial Phase

Not Listed

Enrollment Quota

140

Sponsor

Northwell Health

Inclusion Criteria

1. Patient receiving ERCP as standard of care for suspected or documented choledocholithiasis as assessed by one or more of the following: 1. Abnormal imaging on ultrasound, endoscopic ultrasound (EUS), CT scan, or MRCP suggestive of choledocholithiasis 2. Clinical signs and symptoms suggestive of choledocholithiasis such as jaundice, abdominal pain, pruritis, pancreatitis, and/or cholangitis 3. Abnormal liver function tests suggestive of choledocholithiasis (eg: serum bilirubin > 1.5 and/or elevated alkaline phosphatase levels) 2. In addition to one or more of the above inclusion criteria, patient must also satisfy one or more of the following: 1. Mechanical lithotripsy, electrohydraulic lithotripsy, or laser lithotripsy performed for therapy of bile duct stones. 2. Bile duct > 12mm on prior tests (any portion of duct) 3. History of recurrent abnormal LFTs with negative cholangiogram. 4. Positive EUS or MRCP for biliary stones with a negative cholangiogram

Exclusion Criteria

Billroth II surgery, Roux-en-Y Gastric bypass surgery, and Whipple's surgery.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

Study Locations and Contact Information (2)

Study Location	Distance	Name	Phone	Email
North Shore University Hospital - Manhasset, New York	37.0 miles	Divyesh Sejpal MD	516-387-3990	dsejpal@northwell.edu
LIJ Medical Center NSLIJ Health System - New Hyde Park, New York	39.6 miles	Arvind Trindade MD	718-470-7997	Atrindade@northwell.edu

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