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OpenTrials
Completed

NCT Number: NCT05568433

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

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.

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Key information

Conditions

Pancreatic Cyst Cysts Digestive System Diseases Neoplasms Pancreatic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Cluj-Napoca, Romania

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Endoscopic ultrasound fine needle aspiration (EUS-FNA)

Diagnostic Test

Patients with pancreatic cysts who underwent endoscopic ultrasound and endoscopic fine needle aspiration for diagnostic and therapeutic purpose. A sample of the cyst fluid and frozen serum was collected from the patients and stored at minus 80 degrees.

Other names: ELISA measurements of cystic fluid

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Collaborators

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

Registry information

Official study title

New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 5, 2022
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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