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

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ClinicalTrials.gov Identifier: NCT02703077
Recruitment Status : Unknown
Verified February 2016 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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

Condition or disease Intervention/treatment Phase
Common Bile Duct Gallstones Choledocholithiasis Procedure: Spyglass Procedure: Balloon dilation of the papilla Procedure: EHL (electrohydraulic lithotripsy) Procedure: ERCP (Endoscopic retrograde cholangiopancreatography) Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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: Balloon dilation of the papilla
Using a hidrostatic balloon the major papilla will be dilated to facilitate the stone removal
Other Name: Sphincteroplasty

Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)
Endoscopic procedure to identify and treat biliary diseases




Primary Outcome Measures :
  1. Success of the intervention [ Time Frame: intraoperative ]
    Defined as complete stone removal of the bile duct


Secondary Outcome Measures :
  1. Time [ Time Frame: intraoperative ]
    From ERCP diagnosis to end of procedure (in minutes)

  2. Adverse events [ Time Frame: One week ]
    All procedure related adverse events

  3. X-ray time [ Time Frame: intraoperative ]
    From ERCP diagnosis to end of procedure in minutes

  4. Difficulties [ Time Frame: intraoperative ]
    Procedure related technique difficulties (operator subjective evaluation) : papilla dilation, Spyglass insertion into bile duct, lithotripsy probe introduction, EHL



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703077


Contacts
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Contact: Tomazo Franzini, MD 5511983179968 tomazof@uol.com.br
Contact: Eduardo de Moura, PhD 5511989918060 eduardoghdemoura@gmail.com

Locations
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Brazil
Endoscopy Unit - Clinics Hospital University of Sao Paulo Medical School Recruiting
Sao Paulo, Brazil, 05403000
Contact: Tomazo Franzini, MD    551126617579    tomazof@uol.com.br   
Contact: Eduardo de Moura, PhD    551126616460    eduardoghdemoura@gmail.com   
Principal Investigator: Tomazo Franzini, MD         
Sub-Investigator: Eduardo de Moura, PhD         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Boston Scientific Corporation
Investigators
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Study Director: Eduardo Moura, PhD University of Sao Paulo Medical School

Publications:
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02703077     History of Changes
Other Study ID Numbers: 0784/10
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Decision during trial
Additional relevant MeSH terms:
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Gallstones
Choledocholithiasis
Pathological Conditions, Anatomical
Cholelithiasis
Biliary Tract Diseases
Digestive System Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Common Bile Duct Diseases
Bile Duct Diseases