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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Endoscopic Treatment of Difficult Bile Duct Stones: Use of Direct Visualization System ("Spyglass Direct Visualization System") Associated With Electrohydraulic Lithotripsy (EHL) X Hydrostat

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

Detailed Summary:

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 wil
Sponsor: University of Sao Paulo General Hospital

Current Primary Outcome: Success of the intervention [ Time Frame: intraoperative ]

Defined as complete stone removal of the bile duct


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo General Hospital

Dates:
Date Received: February 29, 2016
Date Started: February 2016
Date Completion: February 2017
Last Updated: March 8, 2016
Last Verified: February 2016