New Biomarkers in the Intracystic Liquid of Inflammatory and Non-inflammatory Pancreatic Cysts

October 4, 2022 updated by: Olar Miruna-Patricia, Iuliu Hatieganu University of Medicine and Pharmacy

New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions

Due to the advances made in the field of the imaging techniques and their common use, pancreatic cysts are more and more incidentally found.

Pancreatic pseudocysts can be misdiagnosed as cystic neoplasms, in particular when there is no clinical history of acute or chronic pancreatitis. Pancreatic cystic neoplasms on the other hand are rare, but are difficult to diagnose accurately.

Neutrophil gelatinase-associated lipocalin (NGAL) , interleukin 1 Beta (IL1beta) and High Mobility Group AT-Hook 2 (HmgA2) are molecules implicated in the process of inflammation and tumour development. The diagnostic value of their concentration in pancreatic cysts is not established yet.

Study aim to asses the significance of NGAL,IL1Beta and HMGA2 concentration in cystic fluid obtained by endoscopic ultrasound (EUS) with EUS-guided fine-needle aspiration (EUS-FNA) and serum level for discriminating between inflammatory and non-inflammatory pancreatic cyst.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

63

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

  • Romania
      • Cluj-Napoca, Romania
        • Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients aged 18-90 years diagnosed with an unclear specific diagnosis of pancreatic cysts >15mm on Computer tomography scan (CT) or Magnetic resonance imaging (MRI) and patients with pseudocysts with indication for drainage , admitted to our hospital (the Regional Institute of Gastroenterology and Hepatology in Cluj-Napoca, Romania)

Description

Inclusion Criteria:

  • patients aged 18-90 years with an unclear specific diagnosis of pancreatic cysts
  • pancreatic cyst >15mm on CT or MRI
  • patients with pseudocysts with indication for drainage

Exclusion Criteria:

  • refusal to participate
  • platelet level < 50000/mm3 and International normalized ratio (INR >1.5)
  • duodenal stenosis
  • severe chronic pancreatitis
  • history of pancreatic cancer or major upper abdominal surgery
  • congestive heart failure
  • the liquid sample < 1ml;

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Role of the cyst fluid concentrations of the specific biomarkers for differentiation the pancreatic cystic lesions
Time Frame: through study completion, an average of 1 year
Measurement the cyst fluid concentration of NGAL, IL1beta, HMGA2, expressed in nanograms/dl
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Correlation between cyst fluid concentration and serum level of the specific biomarkers
Time Frame: through study completion, an average of 1 year
coefficient of correlation between the two values
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Collaborators

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Investigators

  • Study Director: Andrada Seicean, Professor, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 2, 2018

Primary Completion (Actual)

November 30, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

September 25, 2022

First Submitted That Met QC Criteria

October 4, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202042018

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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