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

Completed

Conditions studied: Gall Stones

In brief

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.

Key facts

Study ID

NCT03482375

Run by

Northwell Health

People needed

140

Starts

2015-12-17

Expected to finish

2019-02-10

Last updated by the study team

2019-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• North Shore University Hospital — Manhasset, New York, United States
• LIJ Medical Center- NSLIJ Health System — New Hyde Park, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.