Choledocholithiasis
Conditions
Interventions
The sample will include the selection of 100 patients diagnosed with cholelithiasis and with clinical suspicion of choledocholithiasis. Patients will be submitted to clinical screening, with risk stra
E04.210.120.172
E01.370.372.250.200
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Eligibility
Age
10 Years to 90 Years
Inclusion criteria
Inclusion criteria: Volunteers with symptomatic cholelithiasis; healthy or with controlled morbidities; both genders; age between 10 and 90 years; with clinical suspicion of choledocholithiasis
Exclusion criteria
Exclusion criteria: Volunteers with undefined clinical or laboratory cholestasis; with a history of coagulopathies; diagnosed with malignant neoplasms or disproportionate biliary tract
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the effectiveness of treatment between groups. The effectiveness will be evaluated by clearing the biliary tract, by cholangiography performed at the end of the extraction of bile duct intraoperatively. It is expected to be similar between the two groups, with rates close to 98% for group I and 96% for group II.;Evaluate the complication rate between groups using the Clavien Dindo classification. It is expected that there will be a lower rate of complications in group I, as it is a less invasive technique, around 3 to 5% of minor complications, and serious complications are not expected.;Assess the cost of treatment between groups. This evaluation will be carried out through the analysis of health costs using the micro-costing methodology. It is expected that there will be a higher cost in the treatment of group II, based on the results of retrospective studies with cost analysis.;Assess mortality at the end of the study follow-up. The mortality rate will be evaluated based on the frequency of death by group and comparison between them. Mortality is not expected in any of the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate cost-effectiveness between groups. This assessment will be performed by analyzing the comparison between costs and effectiveness between the two groups, by the cost-effectiveness ratio, per patient and per group. It is expected that there will be a better cost-effectiveness (RCE) for the treatment group with outpatient endoscopic access (group I).;Compare the two techniques of access to the biliary tree in the treatment of choledocholithiasis in order to elaborate and the selection criteria for the treatment of cholelithiasis with choledocholithiasis by laparoendoscopic technique (group I) and in an outpatient setting. | — |
Countries
Brazil
Contacts
Public ContactLeonardo Lima
Outcome results
None listed