Clinical trial · Observational
New Biomarkers in the Intracystic Liquid of Inflammatory and Non-inflammatory Pancreatic Cysts
New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic ultrasound fine needle aspiration (EUS-FNA) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- Measurement the cyst fluid concentration of NGAL, IL1beta, HMGA2, expressed in nanograms/dl
Secondary outcomes (1)
- measure
- The Correlation between cyst fluid concentration and serum level of the specific biomarkers
- timeFrame
- through study completion, an average of 1 year
- description
- coefficient of correlation between the two values
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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;
References
Publications (10)
- BACKGROUNDTan 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. PMID 33456526
- BACKGROUNDDel Chiaro M, Segersvard R, Pozzi Mucelli R, Rangelova E, Kartalis N, Ansorge C, Arnelo U, Blomberg J, Lohr 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. PMID 24385209
- BACKGROUNDvan 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. PMID 31527862
- BACKGROUNDChakraborty 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. PMID 22513004
- BACKGROUNDClerico 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. PMID 22962216
- BACKGROUNDDevarajan 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. No abstract available. PMID 18809975
- BACKGROUNDBhatia 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.