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Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

Primary Purpose

Bile Duct Stricture, Choledocholithiasis

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Direct peroral cholangioscopy
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bile Duct Stricture focused on measuring cholangioscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soonchunhyang University Bucheon Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MB group

Conventional group

Arm Description

Direct POC performed with third-generation prototype multibending ultra-slim endoscope (CHF-Y0010; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)

Direct POC performed with conventional ultra-slim endoscope (GIF-XP290N; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)

Outcomes

Primary Outcome Measures

The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC
successful insertion of the endoscope through the AOV and advancement up to the bifurcation or obstructed segment of the biliary tree, without any accessories

Secondary Outcome Measures

Procedure time required for free-hand insertion
Procedure time required for free-hand insertion
The technical success of diagnostic and therapeutic interventions
The technical success of diagnostic and therapeutic interventions
Adverse events related to direct POC
perforation, cholangitis, pancreatitis, and air embolism

Full Information

First Posted
October 21, 2014
Last Updated
October 26, 2022
Sponsor
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02276157
Brief Title
Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope
Official Title
A Prospective Randomized Trial of a New Multibending Versus Conventional Ultra-slim Endoscope for Direct Peroral Cholangioscopy Without Device Assistance
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Stricture, Choledocholithiasis
Keywords
cholangioscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MB group
Arm Type
Experimental
Arm Description
Direct POC performed with third-generation prototype multibending ultra-slim endoscope (CHF-Y0010; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
Direct POC performed with conventional ultra-slim endoscope (GIF-XP290N; Olympus Medical Systems, Co., Ltd., Tokyo, Japan)
Intervention Type
Device
Intervention Name(s)
Direct peroral cholangioscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC
Description
successful insertion of the endoscope through the AOV and advancement up to the bifurcation or obstructed segment of the biliary tree, without any accessories
Time Frame
within 15 min after insertion of endoscope into the mouth
Secondary Outcome Measure Information:
Title
Procedure time required for free-hand insertion
Description
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
Title
The technical success of diagnostic and therapeutic interventions
Description
The technical success of diagnostic and therapeutic interventions
Time Frame
Within 24 hours after Completion of DPOC
Title
Adverse events related to direct POC
Description
perforation, cholangitis, pancreatitis, and air embolism
Time Frame
Within 7 days after DPOC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Moon, M.D., Ph.D.
Organizational Affiliation
SoonChunHyang University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
ZIP/Postal Code
420-767
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23127575
Citation
Moon JH, Terheggen G, Choi HJ, Neuhaus H. Peroral cholangioscopy: diagnostic and therapeutic applications. Gastroenterology. 2013 Feb;144(2):276-282. doi: 10.1053/j.gastro.2012.10.045. Epub 2012 Nov 2. No abstract available.
Results Reference
background
PubMed Identifier
17466202
Citation
Chen YK, Pleskow DK. SpyGlass single-operator peroral cholangiopancreatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video). Gastrointest Endosc. 2007 May;65(6):832-41. doi: 10.1016/j.gie.2007.01.025.
Results Reference
result
PubMed Identifier
19327480
Citation
Choi HJ, Moon JH, Ko BM, Hong SJ, Koo HC, Cheon YK, Cho YD, Lee JS, Lee MS, Shim CS. Overtube-balloon-assisted direct peroral cholangioscopy by using an ultra-slim upper endoscope (with videos). Gastrointest Endosc. 2009 Apr;69(4):935-40. doi: 10.1016/j.gie.2008.08.043.
Results Reference
result
PubMed Identifier
19394010
Citation
Moon JH, Ko BM, Choi HJ, Hong SJ, Cheon YK, Cho YD, Lee JS, Lee MS, Shim CS. Intraductal balloon-guided direct peroral cholangioscopy with an ultraslim upper endoscope (with videos). Gastrointest Endosc. 2009 Aug;70(2):297-302. doi: 10.1016/j.gie.2008.11.019. Epub 2009 Apr 25.
Results Reference
result
PubMed Identifier
19623165
Citation
Moon JH, Ko BM, Choi HJ, Koo HC, Hong SJ, Cheon YK, Cho YD, Lee MS, Shim CS. Direct peroral cholangioscopy using an ultra-slim upper endoscope for the treatment of retained bile duct stones. Am J Gastroenterol. 2009 Nov;104(11):2729-33. doi: 10.1038/ajg.2009.435. Epub 2009 Jul 21.
Results Reference
result
PubMed Identifier
21762903
Citation
Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Deviere J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805-14. doi: 10.1016/j.gie.2011.04.016. Epub 2011 Jul 18.
Results Reference
result

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Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

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