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Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Primary Purpose

Common Bile Duct Diseases, Stone - Biliary, Cholangitis, Sclerosing

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)

About this trial

This is an interventional treatment trial for Common Bile Duct Diseases focused on measuring common bile duct stone, cholangioscopy, SpyGlass, non-fluoroscopic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ERCP without Fluoroscopy

Arm Description

Non-fluoroscopic common bile duct stone extraction

Outcomes

Primary Outcome Measures

Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

Secondary Outcome Measures

Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

Full Information

NCT ID

NCT02967926

First Posted

November 3, 2016

Last Updated

November 16, 2016

Sponsor

Chulalongkorn University

Collaborators

Boston Scientific Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02967926

Brief Title

Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Official Title

Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

December 2015 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chulalongkorn University

Collaborators

Boston Scientific Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Bile Duct Diseases, Stone - Biliary, Cholangitis, Sclerosing

Keywords

common bile duct stone, cholangioscopy, SpyGlass, non-fluoroscopic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ERCP without Fluoroscopy

Arm Type

Experimental

Arm Description

Non-fluoroscopic common bile duct stone extraction

Intervention Type

Procedure

Intervention Name(s)

Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)

Intervention Description

Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal

Primary Outcome Measure Information:

Title

Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal

Time Frame

1 year

Other Pre-specified Outcome Measures:

Title

Procedural time

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

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