NCT06552208

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

August 9, 2024

Last Update Submit

August 9, 2024

Conditions

Malignant Biliary Obstruction

Keywords

Prognostic scoreBiliary drainage30-day survival

Outcome Measures

Primary Outcomes (1)

  • Short-term survival after biliary drainage

    30-day survival after biliary drainage

    4 years and fifth months

Secondary Outcomes (1)

  • Prognostic score

    4 years and fifth months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The cohort will be selected from the general population of Brest, Finistère.

You may qualify if:

  • Malignant Biliary obstruction : cholestasis (elevated bilirubin \> 40 µmol/L or alkaline phosphatase \> 1.5 time than the normal value) and dilation of biliary tract

You may not qualify if:

  • Benign obstruction
  • Post stent surgery
  • First stent placed outside Brest University Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

July 15, 2021

Primary Completion

July 15, 2021

Study Completion

October 15, 2021

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning one year and ending three years following the publication
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR(1)