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

Matrix Metalloproteinase Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801914
• Other study ID #: 717/11
• Status: Recruiting
• Start date: December 11, 2020
• Est. completion date: May 11, 2021

Study information

• Verified date: March 2021
• Source: Institut za Rehabilitaciju Sokobanjska Beograd
• Contact: Aleksandar N Filipovic, Dr
• Phone: +381658832505
• Email: aleksandar.filipovic11[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 11, 2021
• Est. primary completion date: March 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Jaundice, Obstructive
• Matrix Metalloproteinase

Intervention

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).

Locations

Country	Name	City	State
Serbia	University Clinical Center of Serbia	Belgrade

Sponsors (2)

Lead Sponsor	Collaborator
Institut za Rehabilitaciju Sokobanjska Beograd	Klinicki centar Srbije

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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