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

New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05568433

Enrollment

Registered

2022-10-05

Start date

2018-04-02

Completion date

2020-11-30

Last updated

2022-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cyst

Keywords

pancreatic cyst, EUS-FNA, intracystic fluid

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.

Interventions

DIAGNOSTIC_TESTEndoscopic ultrasound fine needle aspiration (EUS-FNA)

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

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;

Design outcomes

Primary

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

Secondary

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

Countries

Romania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026