Status:
UNKNOWN
Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy
Lead Sponsor:
Soonchunhyang University Hospital
Conditions:
Common Bile Duct Calculi
Biliary Tract Cancer
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the usefulness of a newly developed multibending ultra-slim upper endoscope for the successful direct peroral cholangioscopy (POC) without assisting accessory in c...
Detailed Description
Direct POC using an ultra-slim upper endoscope permits various diagnostic and/or therapeutic intraductal interventions under direct endoscopic visualization in selected patients who has dilated distal...
Eligibility Criteria
Inclusion
- Pancreatobiliary diseases that are indicated for direct POC
- The patient who aged from 20 to 80 years. Legally acceptable representative must be capable of giving written informed consent prior to participation in this study
- The woman of child-bearing age must be negative from the pregnancy test in order to participate in this study
- Dilated common bile duct (\> 8 mm)
- Having previous sphincterotomy and/or papillary balloon dilation
- The patients should not have any unacceptable conditions (e.g., physiological, familyish, social, geographical) for medical follow-up and adaptation of the study.
Exclusion
- Contraindicated for ERCP
- Patients with stricture on papillary orifice
- Patients with periampullary malignancy
- Bleeding tendency: International normalized ratio (INR) of prothrombin time \< 1.5 or platelet count \< 60,000/mm3
- Patients with other serious disease or medical condition
- Patients with past medical history of significant neurologic or Psychiatric disorders such as dementia or seizure
- Unstable heart disease despite of treatment, recent myocardial infarction within 6 month (Even though MI was diagnosed within 6 months, if it becomes stable presently, the patient can be possible to participate).
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2016
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02189421
Start Date
April 1 2014
End Date
February 1 2016
Last Update
November 3 2015
Active Locations (1)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea, 420-767