Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy

October 30, 2015 updated by: Hyun Jong Choi, Soonchunhyang University Hospital

Comparison of Multibending and Conventional Ultra-slim Upper Endoscope for the Direct Advance Into the Bile Duct Without Assisting Accessory in Peroral Cholangioscopy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of, 420-767
        • SoonChunHyang University Bucheon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Direct peroral cholangioscopy
Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
Device: ultra-slim upper endoscope
Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
Other Names:
  • CHF-Y0009
  • GIF-XP290N

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success of the direct peroral cholangioscopy
Time Frame: 6 months
Successful insertion of a slim endoscope into the bile duct in no assisting accessories.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events associated with direct POC
Time Frame: 6 months
  1. Cholangitis: fever and abdominal pain with abnormal liver function test
  2. Hemobilia: bleeding from the bile duct
  3. Pancreatitis: abdominal pain with elevation of the serum amylase and lipase
  4. Bile duct perforation: any evidence of bile duct perforation in imaging studies.
  5. Air embolism: clinical and imagine findings with air embolism
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Investigators

  • Principal Investigator: Jong Ho Moon, MD, PhD, SoonChunHyang University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHBC 2014-06-012-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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