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Pancreatic CystNCT05568433

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

An observational study of Pancreatic Cyst, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Pancreatic Cyst
What is being tested?
Endoscopic ultrasound fine needle aspiration (EUS-FNA)
How many people
63 participants
Where
1 siteRomania
Study dates
2 Apr 2018to 30 Nov 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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)

Who may be able to join

  • 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

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Romania1 site

  • Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

    Cluj-Napoca

Other trials in Romania

About this study

Official title: New Biomarkers in the Intracystic Liquid of Cystic Pancreatic Lesions

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.

Read more

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
Pancreatic Cyst
Being tested
Endoscopic ultrasound fine needle aspiration (EUS-FNA)
Keywords
pancreatic cyst, EUS-FNA, intracystic fluid
Medical subject headings
Pancreatic Cyst

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic ultrasound fine needle aspiration (EUS-FNA)Diagnostic test

    Also called ELISA measurements of cystic fluid

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: through study completion, an average of 1 year

Secondary outcomes (1)

  1. The Correlation between cyst fluid concentration and serum level of the specific biomarkers

    coefficient of correlation between the two values

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2022
  2. Study start2 Apr 2018
  3. Primary completion30 Nov 2020
  4. Study completion30 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05568433
Sponsor's protocol ID
202042018
Status last verified
Oct 2022
First submitted
25 Sep 2022
Last updated
5 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33456526

  • Del 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.

    PubMed 24385209

  • 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.

    PubMed 31527862

  • 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.

    PubMed 22513004

  • 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.

    PubMed 22962216

  • 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. No abstract available.

    PubMed 18809975

  • 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.

    PubMed 33122517

  • 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.

    PubMed 20179686

  • Santiago-Sanchez GS, Pita-Grisanti V, Quinones-Diaz B, Gumpper K, Cruz-Monserrate Z, Vivas-Mejia PE. Biological Functions and Therapeutic Potential of Lipocalin 2 in Cancer. Int J Mol Sci. 2020 Jun 19;21(12):4365. doi: 10.3390/ijms21124365.

    PubMed 32575507

  • 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.

    PubMed 23146921

Questions about this trial

What is this clinical trial studying?

An observational study of Pancreatic Cyst, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Role of the cyst fluid concentrations of the specific biomarkers for differentiation the pancreatic cystic lesions (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05568433, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.

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