Status:
COMPLETED
Prospective Evaluation of Residual Bile Duct Stone by Peroral Cholangioscopy After Conventional ERCP
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Gall Stones
Eligibility:
All Genders
18+ years
Brief 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 retr...
Detailed Description
Peroral cholangioscopy (POC) provides direct visualization of the bile duct during ERCP and its benefits are well documented in numerous published studies. POC has been described for therapy of diffic...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients less than 18 years of age.
- Patients not undergoing ERCP as their standard of care.
- Patients who had the following surgeries - Billroth II surgery, Roux-en-Y Gastric bypass surgery, and Whipple's surgery.
Key Trial Info
Start Date :
December 17 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 10 2019
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03482375
Start Date
December 17 2015
End Date
February 10 2019
Last Update
February 19 2019
Active Locations (2)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030
2
LIJ Medical Center- NSLIJ Health System
New Hyde Park, New York, United States, 11040