Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

• Sponsor: Chulalongkorn University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02967926
• Collaborator: Boston Scientific Corporation (Industry)
• Enrollment: 51
• Arm: 1
• Duration (Months): 11

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Common Bile Duct Diseases; Stone - Biliary; Cholangitis, Sclerosing	Procedure: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy
• Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ERCP without Fluoroscopy Non-fluoroscopic common bile duct stone extraction	Procedure: Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS); Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal

Outcome Measures

Primary Outcome Measures

1. Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal [1 year]

Secondary Outcome Measures

1. Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal [1 year]

Other Outcome Measures

1. Procedural time [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chulalongkorn University
• Boston Scientific Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thanawat Luangsukrerk, Gastrointestinal Endoscopy Excellence Center, Chulalongkorn University
• ClinicalTrials.gov Identifier: NCT02967926
• Other Study ID Numbers: 791/2016
• First Posted: Nov 18, 2016
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Thanawat Luangsukrerk, Gastrointestinal Endoscopy Excellence Center, Chulalongkorn University: common bile duct stone; cholangioscopy; SpyGlass; non-fluoroscopic
• Additional relevant MeSH terms: Cholangitis; Bile Duct Diseases; Cholangitis, Sclerosing; Common Bile Duct Diseases; Cholelithiasis; Cholecystolithiasis; Gallstones; Calculi

Study Results

No Results Posted as of Nov 18, 2016