Clinical trial NCT05568433: New Biomarkers in the Intracystic Liquid of Inflammatory and Non-inflammatory Pancreatic Cysts
Official title: New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cyst
Keywords: pancreatic cyst
EUS-FNA
intracystic fluid
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
Collaborators: name: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
First posted: 2022-10-05
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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)

Brief summary: 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.


Eligibility criteria: 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;

Primary outcomes:
measure: Role of the cyst fluid concentrations of the specific biomarkers for differentiation the pancreatic cystic lesions
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The Correlation between cyst fluid concentration and serum level of the specific biomarkers
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
Study officials:
affiliation: Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor
name: Andrada Seicean, Professor
role: STUDY_DIRECTOR
References:
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