Direct Peroral Cholangioscopy by Using an Ultra-slim Upper Endoscope

NCT02276157 | Completed DMC

• 1 other identifier: 2014-07-026
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Bile Duct Stricture; Choledocholithiasis

Keywords

cholangioscopy

Outcome Measures

Primary Outcomes (1)

• 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

  within 15 min after insertion of endoscope into the mouth

Secondary Outcomes (3)

• 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

  Within 24 hours after Completion of DPOC

• Adverse events related to direct POC

  Within 7 days after DPOC

Study Arms (2)

MB group

EXPERIMENTAL

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

Device: Direct peroral cholangioscopy

Conventional group

ACTIVE COMPARATOR

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

Device: Direct peroral cholangioscopy

Interventions

Direct peroral cholangioscopy DEVICE

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.

Conventional group; MB group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Bucheon Hospital

Bucheon-si, 420-767, South Korea

Location

Related Publications (6)

• 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.

  PMID: 23127575 BACKGROUND

• 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.

  PMID: 17466202 RESULT

• 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.

  PMID: 19327480 RESULT

• 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.

  PMID: 19394010 RESULT

• 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.

  PMID: 19623165 RESULT

• 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.

  PMID: 21762903 RESULT

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Study Officials

• Jong Ho Moon, M.D., Ph.D.

  SoonChunHyang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 28, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

KR (1)