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

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

Unknown

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

    1. Patients less than 18 years of age. 2. Patients not undergoing ERCP as their standard of care. 3. Patients who had the following surgeries
  • Billroth II surgery, Roux-en-Y Gastric bypass surgery, and Whipple's surgery.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

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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