Endoscopic Treatment of Difficult Bile Duct Stones: Spyglass + EHL x Balloon Dilation of the Papilla
- Conditions
- Common Bile Duct GallstonesCholedocholithiasis
- Interventions
- Procedure: SpyglassProcedure: Balloon dilation of the papillaProcedure: EHL (electrohydraulic lithotripsy)Procedure: ERCP (Endoscopic retrograde cholangiopancreatography)
- Registration Number
- NCT02703077
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
This study compare 2 techniques to treat difficult bile duct stones endoscopically
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1: ERCP + Spyglass + EHL ERCP (Endoscopic retrograde cholangiopancreatography) This group after the diagnosis of difficult bile duct stones, will be submitted to spyglass cholangioscopy + EHL (electrohydraulic lithotripsy) 1: ERCP + Spyglass + EHL Spyglass This group after the diagnosis of difficult bile duct stones, will be submitted to spyglass cholangioscopy + EHL (electrohydraulic lithotripsy) 1: ERCP + Spyglass + EHL EHL (electrohydraulic lithotripsy) This group after the diagnosis of difficult bile duct stones, will be submitted to spyglass cholangioscopy + EHL (electrohydraulic lithotripsy) 2: ERCP + Balloon Dilation Balloon dilation of the papilla This group after the diagnosis of difficult bile duct stones, will be submitted to Balloon dilation of the papilla 2: ERCP + Balloon Dilation ERCP (Endoscopic retrograde cholangiopancreatography) This group after the diagnosis of difficult bile duct stones, will be submitted to Balloon dilation of the papilla
- Primary Outcome Measures
Name Time Method Success of the intervention intraoperative Defined as complete stone removal of the bile duct
- Secondary Outcome Measures
Name Time Method Difficulties intraoperative Procedure related technique difficulties (operator subjective evaluation) : papilla dilation, Spyglass insertion into bile duct, lithotripsy probe introduction, EHL
Adverse events One week All procedure related adverse events
Time intraoperative From ERCP diagnosis to end of procedure (in minutes)
X-ray time intraoperative From ERCP diagnosis to end of procedure in minutes
Trial Locations
- Locations (1)
Endoscopy Unit - Clinics Hospital University of Sao Paulo Medical School
🇧🇷Sao Paulo, Brazil