Elaboration of a Prognostic Score Based on Patients With Malignant Biliary Obstruction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Brest
- Enrollment
- 372
- Locations
- 1
- Primary Endpoint
- Short-term survival after biliary drainage
Study Overview
Brief Summary
Inclusion of patients with biliary drainage for inoperable malignant biliary obstruction and analysis of clinico-biological parameters
Detailed Description
All patients who had biliary drainage between April 1, 2014 and August 31, 2018 for inoperable malignant biliary obstruction will be included.
Clinical and biological baseline data will be recorded retrospectively. From the electronic medical records (M-Eva software), the following clinical data will be retrieved on the day of procedure: age, gender, body mass index (BMI), percentage of weight loss in the last three months, American Society of Anesthesiologists score (ASA) , Charlson score, Eastern Cooperative Oncology Group Performans Status (ECOG PS), comorbidities, cancer type, liver metastases, obstruction level, pre-procedural sepsis, type of procedure and type of stent.
Serum biological parameters will be recorded: hemoglobin, platelets, leukocytes, urea, creatinine, albumin, total bilirubin and prothrombin time, within 48 hours prior to the procedure.
The continuous variables of biological tests will be analyzed by ROC curves. The survival curves will be estimated using the Kaplan-Meier method and compared using the log-rank test. A prognostic index will be established from the variables independently associated with poor prognosis.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Malignant Biliary obstruction : cholestasis (elevated bilirubin > 40 µmol/L or alkaline phosphatase > 1.5 time than the normal value) and dilation of biliary tract
Exclusion Criteria
- •Benign obstruction
- •Post stent surgery
- •First stent placed outside Brest University Hospital
Outcomes
Primary Outcomes
Short-term survival after biliary drainage
Time Frame: 4 years and fifth months
30-day survival after biliary drainage
Secondary Outcomes
- Prognostic score(4 years and fifth months)