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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06552208

Acronym

PROBILI

Enrollment

372

Registered

2024-08-13

Start date

2021-07-15

Completion date

2021-10-15

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Biliary Obstruction

Keywords

Prognostic score, Biliary drainage, 30-day survival

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
Short-term survival after biliary drainage	4 years and fifth months	30-day survival after biliary drainage

Secondary

Measure	Time frame	Description
Prognostic score	4 years and fifth months	To establish a prognostic score

Countries

France

Outcome results