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

Completed

• Conditions: Malignant Biliary Obstruction

• Registration Number: NCT06552208
• Lead Sponsor: University Hospital, Brest

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 Timeline

• Study Start: 2021-07-15
• Primary Completion: 2021-07-15
• Study Completion: 2021-10-15
• Status Verified: 2024-08
• Study First Submitted: 2024-08-09
• Study First Submitted QC: 2024-08-09
• Last Update Submitted: 2024-08-09
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 372

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short-term survival after biliary drainage	4 years and fifth months	30-day survival after biliary drainage

Secondary Outcome Measures

Name	Time	Method
Prognostic score	4 years and fifth months	To establish a prognostic score

Trial Locations

Locations (1)

CHRU de Brest; 🇫🇷 Brest, France