Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

November 16, 2016 updated by: Thanawat Luangsukrerk, Chulalongkorn University

Digital SpyGlass Cholangioscopy Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication rate of SpyGlass assisted non-fluoroscopic common bile duct stones removal
Time Frame: 1 year
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Procedural time
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Collaborators

Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 791/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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