ClinicalTrials.gg
Status unknownNCT04801914Updated Mar 17, 2021

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

An observational study in Matrix Metalloproteinase, sponsored by Institut za Rehabilitaciju Sokobanjska Beograd. Status unknown at 1 site in Serbia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-17.

Sponsored by Institut za Rehabilitaciju Sokobanjska Beograd · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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).

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Conditions studied

  • Matrix Metalloproteinase

Keywords

  • biliary drainage, matrix metalloproteinases
03

In context

Lead sponsor

Institut za Rehabilitaciju Sokobanjska Beograd is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Matrix Metalloproteinases

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

    Procedure: Percutaneous biliary drainage

Interventions

  • ProcedurePercutaneous 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).

    Also known as: Matrix Metalloproteinase serum activity measurement

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What researchers measure

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

    Time frame: during intervention

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Study locations

1 of 1 sites recruiting
  • University Clinical Center of Serbia
    Belgrade, 11000, Serbia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2020 (actual). Primary completion is estimated for Mar 2021, 3 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2021
First posted
Mar 17, 2021
StartActual
Dec 11, 2020
Primary completionEst.
Mar 11, 2021
CompletionEst.
May 11, 2021
Last update
Mar 17, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04801914
Lead sponsor
Institut za Rehabilitaciju Sokobanjska Beograd
Collaborators
Klinički centar Srbije
Responsible party
Tamara Filipovic (Phd, Institut za Rehabilitaciju Sokobanjska Beograd) — Principal investigator
First posted
Mar 17, 2021
Start date
Dec 11, 2020
Primary completion
Mar 11, 2021 (estimated)
Completion
May 11, 2021 (estimated)
Last update
Mar 17, 2021

Study contacts

Aleksandar N Filipovic, Dr
Contact
aleksandar.filipovic11@gmail.com
+381658832505
Kristina Gopcevic, Phd
study director · Institute for chemistry in medicine, Medical school, University of Belgrade

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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