NCT06552208

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

Elaboration of a Prognostic Score Based on Patients With Malignant Biliary Obstruction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 372 (actual)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Biliary Obstruction

Timeline

• Start date: 2021-07-15
• Primary completion: 2021-07-15
• Completion: 2021-10-15
• First posted: 2024-08-13
• Last updated: 2024-08-13

Locations

1 site across 1 country: France