Enzyme Activity of Matrix Metalloproteinases in the Serum of Patients With Malignant Obstructive Hyperbilirubinemia Before and After PTBD

March 13, 2021 updated by: Tamara Filipovic, Institut za Rehabilitaciju Sokobanjska Beograd

Influence of Percutaneous Biliary Drainage on the Change of Enzyme Activity of Matrix Metalloproteinases in the Serum of Patients With Malignant Obstructive Hyperbilirubinemia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study will be designed as a prospective cohort study involving the collection of peripheral blood samples before and one month after percutaneous biliary drainage for further molecular biochemical analysis (measurement of serum matrix metalloproteinase activity). Biochemical analyzes are preceded by the entry of data relevant to the research (demographic, anamnestic, clinical and biochemical).

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Matrix Metalloproteinases
Value of serum matrix metalloproteinase activity before and one month after PTBD
Procedure: Percutaneous biliary drainage
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).
Other Names:
  • Matrix Metalloproteinase serum activity measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMP-2 and MMP-9 serum activity
Time Frame: during intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut za Rehabilitaciju Sokobanjska Beograd

Collaborators

Klinički centar Srbije

Investigators

  • Study Director: Kristina Gopcevic, Phd, Institute for chemistry in medicine, Medical school, University of Belgrade

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2020

Primary Completion (Anticipated)

March 11, 2021

Study Completion (Anticipated)

May 11, 2021

Study Registration Dates

First Submitted

March 13, 2021

First Submitted That Met QC Criteria

March 13, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 13, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 717/11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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