Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

October 26, 2022 updated by: Jong Ho Moon, Soonchunhyang University Hospital

A Prospective Randomized Trial of a New Multibending Versus Conventional Ultra-slim Endoscope for Direct Peroral Cholangioscopy Without Device Assistance

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 duct for direct POC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. In this study, the investigators evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories. The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, which was defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 min.

Study Type

Interventional

Enrollment (Actual)

92

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MB group
Direct POC performed with third-generation prototype multibending ultra-slim endoscope (CHF-Y0010; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)
Device: Direct peroral cholangioscopy
The multibending (MB) or conventional ultra-slim endoscope was inserted through the mouth. After facing the papillary orifice, the endoscope was inserted directly, without any accessories, into the distal bile duct. The second bending of the MB ultra-slim endoscope was kept in an upward angled position to achieve a more acute angle of the endoscope tip for entering the distal CBD. Then, the endoscope was pushed by steering the first bend into an upward angle ("α" shape) or the endoscope was pulled by steering the first bend into an upward angle and torqueing it counter-clockwise ("u" shape) for insertion into the distal CBD. If the distal bile duct was visualized on an endoscopic view, carbon dioxide insufflation was stopped. The endoscope was advanced into the hilum or the obstructed segment of the extrahepatic bile duct under fluoroscopic and endoscopic control. Then, the diagnostic and therapeutic interventions were performed during direct POC as necessary.
Active Comparator: Conventional group
Direct POC performed with conventional ultra-slim endoscope (GIF-XP290N; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)
Device: Direct peroral cholangioscopy
The multibending (MB) or conventional ultra-slim endoscope was inserted through the mouth. After facing the papillary orifice, the endoscope was inserted directly, without any accessories, into the distal bile duct. The second bending of the MB ultra-slim endoscope was kept in an upward angled position to achieve a more acute angle of the endoscope tip for entering the distal CBD. Then, the endoscope was pushed by steering the first bend into an upward angle ("α" shape) or the endoscope was pulled by steering the first bend into an upward angle and torqueing it counter-clockwise ("u" shape) for insertion into the distal CBD. If the distal bile duct was visualized on an endoscopic view, carbon dioxide insufflation was stopped. The endoscope was advanced into the hilum or the obstructed segment of the extrahepatic bile duct under fluoroscopic and endoscopic control. Then, the diagnostic and therapeutic interventions were performed during direct POC as necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC
Time Frame: within 15 min after insertion of endoscope into the mouth
successful insertion of the endoscope through the AOV and advancement up to the bifurcation or obstructed segment of the biliary tree, without any accessories
within 15 min after insertion of endoscope into the mouth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time required for free-hand insertion
Time Frame: the time of oral intubation with the ultra-slim endoscope to the time of reaching the obstructed segment of the biliary tree or bifurcation, within 15 min after insertion of endoscope into the mouth
Procedure time required for free-hand insertion
the time of oral intubation with the ultra-slim endoscope to the time of reaching the obstructed segment of the biliary tree or bifurcation, within 15 min after insertion of endoscope into the mouth
The technical success of diagnostic and therapeutic interventions
Time Frame: Within 24 hours after Completion of DPOC
The technical success of diagnostic and therapeutic interventions
Within 24 hours after Completion of DPOC
Adverse events related to direct POC
Time Frame: Within 7 days after DPOC
perforation, cholangitis, pancreatitis, and air embolism
Within 7 days after DPOC

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, M.D., Ph.D., 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

August 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Actual)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-07-026

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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