Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Cholangitis, Sclerosing Clinical Trial

Official title:

Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967926
• Other study ID #: 791/2016
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2016
• Last updated: November 16, 2016
• Start date: December 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Diseases
• Calculi
• Cholangitis
• Cholangitis, Sclerosing
• Cholecystolithiasis
• Cholelithiasis
• Common Bile Duct Diseases
• Gallstones
• Stone - Biliary

Intervention

Procedure:
• Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)
Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	Boston Scientific Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedural time		1 year	No
Primary	Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal		1 year	No
Secondary	Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal		1 year	Yes