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 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


No interventions cited

Study ID

Northwell Health -- HS15-0674



Trial ID


Study Type

Observational [Patient Registry]

Trial Phase

Not Listed

Enrollment Quota



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.




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 172.2 miles Divyesh Sejpal MD 516-387-3990
LIJ Medical Center NSLIJ Health System - New Hyde Park, New York 174.3 miles Arvind Trindade MD 718-470-7997 provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.