Treatment of bile duct stones of difficult removal compared two endoscopic methods: Stone fragmentation with electrohydraulic lithotripsy (EHL) X balloon dilation of the major duodenal papilla
Not Applicable
- Conditions
- C06.130.120.250.174Digestive system diseases.Choledocholithiasis
- Registration Number
- RBR-5wx47j
- Lead Sponsor
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Over 18 years and both genders (male and female). Capable of consent, agreed and signed the Term of Consent. Bile duct stones considered difficult to remove. Biliary stones in bile ducts
Exclusion Criteria
Age below 18 years. Incapable of giving consent. Pregnant. Gastrointestinal bypass surgery with previous reconstructions as 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
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness of the two techniques under investigation.<br>Effectiveness: capacity of the technique to successfully treat the condition (complex biliary stones), with complete removal of all the stones from the bile ducts, in a way that patient will not have this condition at the end of procedure. This will be verified at the end of the procedure performing a control cholangiography post stone removal.
- Secondary Outcome Measures
Name Time Method Analysis of the particularities of the stones (size in millimeters, shape oval, round or faceted and location in bile ducts segments) and their relation with the success of bile duct clearance.;Safety of the two techniques under investigation.<br>Safety: analyzed with the occurrence of adverse events, the frequency, type, if related or not to the procedure and severity. Adverse events were verified during procedure, in 24 hours and one week.