Clinical trial NCT02276157: 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
Overall status: COMPLETED
Phase: NA
Conditions: Bile Duct Stricture
Choledocholithiasis
Keywords: cholangioscopy
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2014-10-28
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: The technical success rate of free-hand insertion of an ultra-slim endoscope during direct POC
timeFrame: within 15 min after insertion of endoscope into the mouth
Secondary outcomes:
measure: Procedure time required for free-hand insertion
timeFrame: 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
measure: The technical success of diagnostic and therapeutic interventions
timeFrame: Within 24 hours after Completion of DPOC
measure: Adverse events related to direct POC
timeFrame: Within 7 days after DPOC
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
Study officials:
affiliation: SoonChunHyang University School of Medicine
name: Jong Ho Moon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.