This trial is active, not recruiting.

Conditions common bile duct calculi, biliary tract cancer, biliary stricture, bile duct diseases
Treatment ultra-slim upper endoscope
Sponsor Soonchunhyang University Hospital
Start date April 2014
End date July 2015
Trial size 110 participants
Trial identifier NCT02189421, SCHBC 2014-06-012-001


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 comparison with conventional ultra-slim endoscope. The investigators expect that multibending endoscope will show more higher successful performance than conventional endoscope.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
ultra-slim upper endoscope CHF-Y0009
Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories

Primary Outcomes

Technical success of the direct peroral cholangioscopy
time frame: 6 months

Secondary Outcomes

Adverse events associated with direct POC
time frame: 6 months

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: - 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 Criteria: - 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).

Additional Information

Official title Comparison of Multibending and Conventional Ultra-slim Upper Endoscope for the Direct Advance Into the Bile Duct Without Assisting Accessory in Peroral Cholangioscopy
Principal investigator Jong Ho Moon, MD, PhD
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 CBD and widened papillary orifice. Because the bile duct has anatomical position in acute angle with the duodenum, assisting accessories such as intraductal anchoring balloon, guidewire or overtube is usually required for the successful direct POC. Recently, direct peroral cholangioscopes have been developed for free-hand direct advancement of the endoscope into the bile duct from duodenum. Multibending ultra-slim endoscope may be expected to facilitate the advance into the bile duct by overcoming the acute angle between the bile duct and the duodenum. After randomization of enrolled patients into two groups, direct POC will be performed by using a conventional slim endoscope in control group and by using a multibending endoscope in study group.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Soonchunhyang University Hospital.