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

NCT ID: NCT06552208

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-15

Study Completion Date

2021-10-15

Brief Summary

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

Detailed Description

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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

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Malignant Biliary Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de Brest

Brest, , France

Site Status

Countries

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France

Other Identifiers

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29BRC18.0197 - PROBILI

Identifier Type: -

Identifier Source: org_study_id

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