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Completed

NCT Number: NCT06552208

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

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

Completed

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Key information

Conditions

Malignant Biliary Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Brest

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Short-term survival after biliary drainage

    Time frame: 4 years and fifth months

    30-day survival after biliary drainage

Secondary outcomes

  1. Prognostic score

    Time frame: 4 years and fifth months

    To establish a prognostic score

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: PROBILI

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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