Biliary Obstruction of Neoplastic Origin Treated With Drainage. A Prognostic Study. (PROBILI)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Malignant Biliary Obstruction

Study type: Observational

Funder types: Other

Identifiers

NCT06552208

29BRC18.0197 - PROBILI

Details and patient eligibility

About

Inclusion of patients with biliary drainage for inoperable malignant biliary obstruction and analysis of clinico-biological parameters

Full 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.

Enrollment: 372 patients

Sex: All

Volunteers: No Healthy Volunteers

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