NCT04801914

Brief Summary

The purpose of this study is to detect differences in the enzymatic activity of matrix metalloproteinases in patients with malignant obstructive hyperbilirubinemia before and after percutaneous biliary drainage.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

December 11, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 13, 2021

Last Update Submit

March 13, 2021

Conditions

Matrix Metalloproteinase

Keywords

biliary drainage, matrix metalloproteinases

Outcome Measures

Primary Outcomes (1)

  • MMP-2 and MMP-9 serum activity

    MMP serume activity will be measured by molecular biochemical analysis performed on peripheral blood samples taken before and one month after percutaneous biliary drainage

    during intervention

Study Arms (1)

Matrix Metalloproteinases

Value of serum matrix metalloproteinase activity before and one month after PTBD

Procedure: Percutaneous biliary drainage

Interventions

Percutaneous biliary drainagePROCEDURE

Collection of peripheral blood samples before and one month after percutaneous biliary drainage performed for patients with malignant obstructive hyperbilirubinemia for further molecular biochemical analysis (measurement of serum matrix metalloproteinase activity).

Also known as: Matrix Metalloproteinase serum activity measurement
Matrix Metalloproteinases

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with malignant obstructive hyperbilirubinemia admitted to hospital and referred to the interventional radiologist for percutaneous biliary drainage.

You may qualify if:

  • pathological confirmation or imaging data confirming malignant disease causing bile duct obstruction, performance status 0-1

You may not qualify if:

  • terminally ill patients, performance status \>2, hepatic decompensation, severe underlying cardiac or renal diseases and coagulation disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinical Center of Serbia

Belgrade, 11000, Serbia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum sample

Study Officials

  • Kristina Gopcevic, Phd

    Institute for chemistry in medicine, Medical school, University of Belgrade

    STUDY DIRECTOR

Central Study Contacts

Aleksandar N Filipovic, Dr

CONTACT

+381658832505aleksandar.filipovic11@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 17, 2021

Study Start

December 11, 2020

Primary Completion

March 11, 2021

Study Completion

May 11, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)