Endoscopic Treatment of Difficult Bile Duct Stones: Spyglass + EHL x Balloon Dilation of the Papilla (EHL)

March 8, 2016 updated by: University of Sao Paulo General Hospital

Endoscopic Treatment of Difficult Bile Duct Stones: Use of Direct Visualization System ("Spyglass Direct Visualization System") Associated With Electrohydraulic Lithotripsy (EHL) X Hydrostatic Balloon Dilation of the Major Duodenal Papilla

This study compare 2 techniques to treat difficult bile duct stones endoscopically

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Before enrollment of the patients into the study, the two investigators, EGHM and TAPF, will perform 10 complete cases each of ERCP (Endoscopic retrograde cholangiopancreatography) + SPYGLASS + EHL, to get more experience with the methods.

This will be a comparative study of methods, prospective, randomized study assessing the successful removal of bile duct stones considered to be difficult between the two proposed methods. A total of 100 patients will be recruited, according to the criteria for inclusion / exclusion of Appendix I. Randomization will be performed using a computer generated system. Fifty patients will be distributed in group 1 (Spyglass + electrohydraulic lithotripsy) and fifty in group 2 (with hydrostatic balloon dilation of the papilla with a extractor balloon sweep). Endoscopic retrograde cholangiopancreatography (ERCP) will be performed, and after the diagnosis of difficult stone, will be followed by randomization between the two proposed methods. In group 1, the examination with the Direct Visualization System of Bile Ducts ("Spyglass Direct Visualization System") will be held soon after the diagnosis of difficult stone and partial endoscopic papillotomy. After access to the biliary duct with the system described, and the visualization of the stone, it will be introduced gently through the working channel of a spyglass the probe to perform the electrohydraulic lithotripsy. When the fragmentation is complete the system spyglass will be removed and the pieces of stone are removed by conventional endoscopic methods. In group 2, after the diagnosis of difficult calculi and performing the partial endoscopic papillotomy, the papilla (as with papillotomy) will be dilated with a hydrostatic balloon until the maximum size allowed by the diameter of common bile duct, followed by scanning with extractor balloon. In both groups, the stone clearance will be confirmed using Spyglass cholangioscopic exploration of the bile duct. In case of failure in stone removal by some of the methods studied, it will be performed biliary drainage with plastic stent.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403000
        • Recruiting
        • Endoscopy Unit - Clinics Hospital University of Sao Paulo Medical School
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomazo Franzini, MD
        • Sub-Investigator:
          • Eduardo de Moura, PhD

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:

  • Over 18 years
  • Able to give consent
  • Submitted to the examination of endoscopic retrograde cholangiopancreatography (ERCP), with identification of stones in the bile duct considered difficult.
  • Agreed and signed the Term of Consent.

Exclusion Criteria:

  • Age below 18 years
  • Incapable of giving consent
  • Pregnant
  • Gastrointestinal bypass surgery with previous reconstructions as a Billroth II or Roux-en-Y
  • Patients with signs of severe acute cholangitis requiring biliary drainage with fast plastic stent and minimal or no contrast infusion
  • Patients with previous liver transplantation

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1: ERCP + Spyglass + EHL
This group after the diagnosis of difficult bile duct stones, will be submitted to spyglass cholangioscopy + EHL (electrohydraulic lithotripsy)
Procedure: Spyglass
Endoscopic direct view of the bile ducts
Other Names:
  • Cholangioscopy
  • Direct view cholangioscopy
Procedure: EHL (electrohydraulic lithotripsy)
With a probe a direct view lithotripsy will be performed
Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)
Endoscopic procedure to identify and treat biliary diseases
Active Comparator: 2: ERCP + Balloon Dilation
This group after the diagnosis of difficult bile duct stones, will be submitted to Balloon dilation of the papilla
Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)
Endoscopic procedure to identify and treat biliary diseases
Procedure: Balloon dilation of the papilla
Using a hidrostatic balloon the major papilla will be dilated to facilitate the stone removal
Other Names:
  • Sphincteroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of the intervention
Time Frame: intraoperative
Defined as complete stone removal of the bile duct
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time
Time Frame: intraoperative
From ERCP diagnosis to end of procedure (in minutes)
intraoperative
Adverse events
Time Frame: One week
All procedure related adverse events
One week
X-ray time
Time Frame: intraoperative
From ERCP diagnosis to end of procedure in minutes
intraoperative
Difficulties
Time Frame: intraoperative
Procedure related technique difficulties (operator subjective evaluation) : papilla dilation, Spyglass insertion into bile duct, lithotripsy probe introduction, EHL
intraoperative

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Collaborators

Boston Scientific Corporation

Investigators

  • Study Director: Eduardo Moura, PhD, University of Sao Paulo Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Estimate)

March 9, 2016

Last Update Submitted That Met QC Criteria

March 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0784/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Decision during trial

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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