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

Pancreatic Cyst Clinical Trial

Official title:

New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05568433
• Other study ID #: 202042018
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: October 2022
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Pancreatic Cyst

Intervention

Diagnostic Test:
• Endoscopic 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.

Locations

Country	Name	City	State
Romania	Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor	Cluj-Napoca

Sponsors (2)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy	Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Country where clinical trial is conducted

Romania, 

References & Publications (10)

Bhatia R, Muniyan S, Thompson CM, Kaur S, Jain M, Singh RK, Dhaliwal A, Cox JL, Akira S, Singh S, Batra SK, Kumar S. Neutrophil Gelatinase-Associated Lipocalin Protects Acinar Cells From Cerulein-Induced Damage During Acute Pancreatitis. Pancreas. 2020 Nov/Dec;49(10):1297-1306. doi: 10.1097/MPA.0000000000001690. — View Citation

Chakraborty S, Kaur S, Guha S, Batra SK. The multifaceted roles of neutrophil gelatinase associated lipocalin (NGAL) in inflammation and cancer. Biochim Biophys Acta. 2012 Aug;1826(1):129-69. doi: 10.1016/j.bbcan.2012.03.008. Epub 2012 Mar 31. Review. — View Citation

Chakraborty S, Kaur S, Muddana V, Sharma N, Wittel UA, Papachristou GI, Whitcomb D, Brand RE, Batra SK. Elevated serum neutrophil gelatinase-associated lipocalin is an early predictor of severity and outcome in acute pancreatitis. Am J Gastroenterol. 2010 Sep;105(9):2050-9. doi: 10.1038/ajg.2010.23. Epub 2010 Feb 23. — View Citation

Clerico A, Galli C, Fortunato A, Ronco C. Neutrophil gelatinase-associated lipocalin (NGAL) as biomarker of acute kidney injury: a review of the laboratory characteristics and clinical evidences. Clin Chem Lab Med. 2012 Feb 15;50(9):1505-17. doi: 10.1515/cclm-2011-0814. Review. — View Citation

Del Chiaro M, Segersvärd R, Pozzi Mucelli R, Rangelova E, Kartalis N, Ansorge C, Arnelo U, Blomberg J, Löhr M, Verbeke C. Comparison of preoperative conference-based diagnosis with histology of cystic tumors of the pancreas. Ann Surg Oncol. 2014 May;21(5):1539-44. doi: 10.1245/s10434-013-3465-9. Epub 2014 Jan 3. — View Citation

Devarajan P. Neutrophil gelatinase-associated lipocalin--an emerging troponin for kidney injury. Nephrol Dial Transplant. 2008 Dec;23(12):3737-43. doi: 10.1093/ndt/gfn531. Epub 2008 Sep 22. Review. — View Citation

Kaur S, Baine MJ, Guha S, Ochi N, Chakraborty S, Mallya K, Thomas C, Crook J, Wallace MB, Woodward TA, Jain M, Singh S, Sasson AR, Skinner V, Raimondo M, Batra SK. Neutrophil gelatinase-associated lipocalin, macrophage inhibitory cytokine 1, and carbohydrate antigen 19-9 in pancreatic juice: pathobiologic implications in diagnosing benign and malignant disease of the pancreas. Pancreas. 2013 Apr;42(3):494-501. doi: 10.1097/MPA.0b013e31826a8597. — View Citation

Santiago-Sánchez GS, Pita-Grisanti V, Quiñones-Díaz B, Gumpper K, Cruz-Monserrate Z, Vivas-Mejía PE. Biological Functions and Therapeutic Potential of Lipocalin 2 in Cancer. Int J Mol Sci. 2020 Jun 19;21(12). pii: E4365. doi: 10.3390/ijms21124365. Review. — View Citation

Tan JH, Chin W, Shaikh AL, Zheng S. Pancreatic pseudocyst: Dilemma of its recent management (Review). Exp Ther Med. 2021 Feb;21(2):159. doi: 10.3892/etm.2020.9590. Epub 2020 Dec 18. Review. — View Citation

van Huijgevoort NCM, Del Chiaro M, Wolfgang CL, van Hooft JE, Besselink MG. Diagnosis and management of pancreatic cystic neoplasms: current evidence and guidelines. Nat Rev Gastroenterol Hepatol. 2019 Nov;16(11):676-689. doi: 10.1038/s41575-019-0195-x. Epub 2019 Sep 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Role of the cyst fluid concentrations of the specific biomarkers for differentiation the pancreatic cystic lesions	Measurement the cyst fluid concentration of NGAL, IL1beta, HMGA2, expressed in nanograms/dl	through study completion, an average of 1 year
Secondary	The Correlation between cyst fluid concentration and serum level of the specific biomarkers	coefficient of correlation between the two values	through study completion, an average of 1 year