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Clinical Trials/NCT04801914
NCT04801914UnknownNot Applicable

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

Institut za Rehabilitaciju Sokobanjska Beograd1 site in 1 country30 target enrollmentStarted: December 11, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
MMP-2 and MMP-9 serum activity

Study Overview

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.

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Institut za Rehabilitaciju Sokobanjska Beograd
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tamara Filipovic

Phd

Institut za Rehabilitaciju Sokobanjska Beograd

Study Sites (1)

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