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
No interventions cited
Northwell Health -- HS15-0674
Observational [Patient Registry]
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
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)
|North Shore University Hospital - Manhasset, New York||172.2 miles||Divyesh Sejpal MDfirstname.lastname@example.org|
|LIJ Medical Center NSLIJ Health System - New Hyde Park, New York||174.3 miles||Arvind Trindade MD||718-470-7997||Atrindade@northwell.edu|