NCT02189421

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

July 9, 2014

Last Update Submit

October 30, 2015

Conditions

Common Bile Duct CalculiBiliary Tract CancerBiliary StrictureBile Duct Diseases

Keywords

peroral cholangioscopyultra-slim upper endoscopemultibending endoscope

Outcome Measures

Primary Outcomes (1)

  • Technical success of the direct peroral cholangioscopy

    Successful insertion of a slim endoscope into the bile duct in no assisting accessories.

    6 months

Secondary Outcomes (1)

  • Adverse events associated with direct POC

    6 months

Study Arms (1)

Direct peroral cholangioscopy

OTHER

Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories

Device: ultra-slim upper endoscope

Interventions

ultra-slim upper endoscopeDEVICE

Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories

Also known as: CHF-Y0009, GIF-XP290N
Direct peroral cholangioscopy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soonchunhyang University Bucheon Hospital

Bucheon-si, 420-767, South Korea

Location

Related Publications (1)

  • Lee YN, Moon JH, Lee TH, Choi HJ, Itoi T, Beyna T, Neuhaus H. Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video). Gastrointest Endosc. 2020 Jan;91(1):92-101. doi: 10.1016/j.gie.2019.08.007. Epub 2019 Aug 20.

    PMID: 31442395DERIVED

MeSH Terms

Conditions

GallstonesBiliary Tract NeoplasmsBile Duct Diseases

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Jong Ho Moon, MD, PhD

    SoonChunHyang University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 9, 2014

First Posted

July 14, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

February 1, 2016

Last Updated

November 3, 2015

Record last verified: 2015-10

Locations

KR(1)