1. Clinical evaluation of a prototype multi-bending peroral direct cholangioscope
- Author
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Takao Itoi, Fumihide Itokawa, Rajesh Gupta, Kentaro Ishii, Mohan Ramchandani, Jong Ho Moon, D. Nageshwar Reddy, Atsushi Sofuni, Nobuhito Ikeuchi, Toshio Kurihara, Fuminori Moriyasu, and Takayoshi Tsuchiya
- Subjects
medicine.medical_specialty ,medicine.medical_treatment ,endoscopic retrograde cholangiopancreatography (ERCP) ,Bile Duct Diseases ,Lithotripsy ,Balloon ,Electrohydraulic lithotripsy ,Stent removal ,Cholelithiasis ,Biopsy ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Endoscopy, Digestive System ,Endoscopes ,medicine.diagnostic_test ,Bile duct ,business.industry ,Gastroenterology ,Equipment Design ,Original Articles ,Surgery ,medicine.anatomical_structure ,Stone removal ,Radiology ,peroral direct cholangioscopy ,business ,Clinical evaluation - Abstract
Background Although peroral direct cholangioscopy (PDCS) is emerging as an alternative to traditional mother-daughter cholangioscopy, it is associated with high failure rates. The aim of the present study was to evaluate the ability to insert and carry out interventions using a prototype multi-bending PDCS. Patients and Methods Prospective, observational clinical feasibility study was done in 41 patients with a variety of biliary diseases. A multi-bending PDCS prototype was inserted using a free-hand technique, a guidewire alone, or with a 5-Fr diameter anchoring balloon. Diagnostic and therapeutic procedures were carried out. Results The free-hand direct insertion technique failed in all attempted cases (n = 7). Of the remaining 34 cases, successful rate of PDCS insertion into the distal bile duct was achieved by passing the PDCS over a guidewire alone (n = 6) and/or with a guidewire plus anchoring balloon (n = 28) for an overall successrate of 88.2% (30/34). In 13 (92.9%) patients without an underlying biliary stricture, PDCS insertion proximal to the bifurcation was possible. In 25 cases, biliary interventions were attempted including biopsy (n = 13), stone removal (n = 6), stent removal (n = 1), and intraductal electrohydraulic lithotripsy (n = 2) and were successful in 22 (88%). Other than two patients with procedure-related cholangitis with a mild grade of severity, no complications were observed. Conclusions Using a novel multi-bending prototype peroral direct cholangioscope, cholangioscopy had a high diagnostic and therapeutic success rate only when passed over a guidewire and anchoring balloon but not with the free-hand insertion technique. Comparative studies of direct cholangioscopy are warranted.
- Published
- 2012