Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552208
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-09
Brief Title:
Biliary Obstruction of Neoplastic Origin Treated With Drainage A Prognostic Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Elaboration of a Prognostic Score Based on Patients With Malignant Biliary Obstruction
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROBILI
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None