Choledocholithiasis Clinical Trial
Official title:
A Prospective Randomized Trial of a New Multibending Versus Conventional Ultra-slim Endoscope for Direct Peroral Cholangioscopy Without Device Assistance
NCT number | NCT02276157 |
Other study ID # | 2014-07-026 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2014 |
Est. completion date | November 2017 |
Verified date | October 2022 |
Source | Soonchunhyang University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 92 |
Est. completion date | November 2017 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Soonchunhyang University Bucheon Hospital | Bucheon |
Lead Sponsor | Collaborator |
---|---|
Soonchunhyang University Hospital |
Korea, Republic of,
Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, Petersen BT, Sherman S, Devière J, Meisner S, Stevens PD, Costamagna G, Ponchon T, Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of b — View 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. — View 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.g — View 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. — View 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.2 — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Procedure time required for free-hand insertion | 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 | |
Secondary | The technical success of diagnostic and therapeutic interventions | The technical success of diagnostic and therapeutic interventions | Within 24 hours after Completion of DPOC | |
Secondary | Adverse events related to direct POC | perforation, cholangitis, pancreatitis, and air embolism | Within 7 days after DPOC |
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