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

Completed

• Conditions: Pancreatic Cyst

• Registration Number: NCT05568433
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-02
• Primary Completion: 2020-11-30
• Study Completion: 2020-11-30
• Study First Submitted: 2022-09-25
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-04
• Last Update Submitted: 2022-10-04
• Study First Posted: 2022-10-05
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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