Status:
COMPLETED
Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope
Lead Sponsor:
Soonchunhyang University Hospital
Conditions:
Bile Duct Stricture
Choledocholithiasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study was aimed to to evaluate the efficacy of the new multibending ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile du...
Detailed Description
Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-s...
Eligibility Criteria
Inclusion
- biliary disease requiring diagnostic and/or therapeutic direct POC
- distal common bile duct (CBD) dilation \> 8 mm
- previous sphincteroplasty, including major endoscopic sphincterotomy and/or endoscopic papillary balloon dilatation during a prior ERCP
- ability to provide informed consent
Exclusion
- presence of any contraindication to ERCP
- bleeding tendency (international normalized ratio \> 1.5 or platelet count \< 50,000/ mm3)
- diffuse stricture of the distal CBD
- diagnosis of pancreatic cancer or tumor at the ampulla of Vater (AOV)
- altered gastrointestinal anatomy or significant duodenal obstruction
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT02276157
Start Date
August 1 2014
End Date
November 1 2017
Last Update
October 31 2022
Active Locations (1)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea, 420-767