Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Phase 3

Completed

• Conditions: Stone - Biliary; Common Bile Duct Diseases; Cholangitis, Sclerosing
• Interventions: Procedure: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)

• Registration Number: NCT02967926
• Lead Sponsor: Chulalongkorn University

Brief Summary

This study aim to evaluated the effectiveness of Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal without fluoroscopy

Detailed Description

Patients This study recruited patients who suspected/confirmed CBDS from clinical manifestation, liver function tests and imaging studies. With CBD sized between 5 and 15 millimeters, which measured from transabdominal ultrasonography (US), computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) or endoscopic ultrasonography (EUS). The exclusion criteria were history of bile duct surgery, bile duct stricture, bile duct tumors, severe comorbid diseases, unstable vital signs, pregnancy, and coagulopathy. All patients were informed and wrote informed consent for the procedure.

Procedures Non-fluoroscopic CBDS removal was performed by experienced endoscopists, using standard side-viewing duodenoscope. After identified major papilla, the investigators performed bile duct cannulation with guidewire assisted technique. Successful cannulation confirmed by visualized bile aspiration. If the patients had difficult cannulation, double guidewire technique was used. After the successful bile duct cannulation, the investigators performed endoscopic standard sphincterotomy (EST). Precut sphincterotomy was not used in this study. Non fluoroscopic balloon extraction was performed. The balloon was pushed up to hilum then the investigators sweep until suspected complete CBD clearance. After that the investigators used digital SpyGlassTM to confirm the complete clearance of CBDS. If SpyGlassTM showed residual CBD stone, the investigators repeat balloon extraction. If SpyGlassTM showed complete clearance, the investigator proceed to perform final cholangiogram as reference standard for this study.

Study Timeline

• Study Start: 2015-12
• Primary Completion: 2016-10
• Status Verified: 2016-11
• Study Completion: 2016-11
• Study First Submitted: 2016-11-03
• Study First Submitted QC: 2016-11-16
• Last Update Submitted: 2016-11-16
• Study First Posted: 2016-11-18
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Patients with clinically suspected/confirmed CBDS
• CBD caliber 5-15 mm

Exclusion Criteria

• History of bile duct surgery
• History of bile duct tumor
• History of bile duct stricture
• Severe comorbidity
• Unstable vital signs
• Pregnancy
• Coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ERCP without Fluoroscopy	Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)	Non-fluoroscopic common bile duct stone extraction

Primary Outcome Measures

Name	Time	Method
Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal	1 year

Secondary Outcome Measures

Name	Time	Method
Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal	1 year