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Contrast Enhanced Ultrasound and Molecular Analysis in the Diagnosis of Pancreatic Cyst

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ClinicalTrials.gov Identifier: NCT03740360
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Brief Summary:
This study evaluates the use of contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) and cyst fluid molecular analysis in the differential diagnosis of pancreatic cysts and the detection of malignancy.

Condition or disease
Pancreatic Cyst

Detailed Description:

Pancreatic cyst are a frequent finding on cross-sectional imaging on general population. They are identified in up to 3% of the abdominal computed tomographies (CT) and 20% of magnetic resonance imaging (MRI) performed for other reasons but the risk of malignancy in pancreatic cysts discovered incidentally is low, representing 1-5% of the total malignant pancreatic neoplasms.

Pancreatic cysts are a broad group of pancreatic lesions that can be divided into benign and premalignant or malignant lesions. Pseudocyst and serous cystic neoplasm (SCN) don´t have malignant potential while others like mucinous cysts are premalignant lesions. But not all mucinous neoplasms have the same risk of malignancy. According to recent publications mucinous cystic neoplasm (MCN) have a potential for malignancy of around 15%, main duct intrapapillary mucinous neoplasm (MD-IPMN) of 62% and branch duct IPMN (BD-IPMN) of 25%. The correct identification of these premalignant lesions will allow to optimize the treatment and follow-up of these patients, but in many cases it is difficult to accurately differentiate between different types of cysts and their risk of malignancy. The differentiation between lmucinous and non-mucinous cysts is suboptimal, with diagnostic accuracy for CT and MRI of 61% and 50-73% with endoscopic ultrasound (EUS). The endosonographic characteristics that have been related with malignancy are the size larger than 3 cm, the presence of a solid component, wall thickening, Wirsung dilation, abrupt change of the size of the main pancreatic duct with distal atrophy of the gland and the presence of lymphadenopathies. However, endosonographic characteristics are not sufficient as an individual predictor of malignancy.

The puncture of the cyst and fine-needle aspiration (EUS-FNA) with biochemical and cytological assessment is generally indicated to differentiate between cysts and to asses for malignancy. The determination of carcinoembryonic antigen (CEA) and amylase have low specificity for the detection of malignancy and for mucinous cyst, and the cytological assessment is highly specific but lacks of sensibility (50%). So further methods are requested for an adequate detection of premalignant and malignant cyst.

Contrast-enhanced harmonic endoscopic ultrasound uses an ultrasonographic contrast agent to visualize blood flow in fine vessels and may aid in the diagnosis of pancreatic cysts by enabling assessment of the vascularization of structures such as cyst walls, septa, or mural nodules. Furthermore it allows the correct differentiation between contrast-enhanced mural nodules, that predict for malignancy, from non-enhancing mucus clots.

The molecular analysis of cyst fluid may detect mutations that are associated with premalignant cyst and with malignancy. Kirsten rat sarcoma (KRAS) gene has been related with mucinous cyst while von Hippel-Lindau gene (VHL) is present in serous cyst.

This study evaluates the use of contrast-enhanced EUS and the molecular analysis for pancreatic cyst diagnosis and malignant detection, and if their use may modify cyst management.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Prospective Analysis About the Utility of Contrast Enhanced Endoscopic Ultrasound and Molecular Analysis in the Study of Pancreatic Cyst
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : October 31, 2019



Primary Outcome Measures :
  1. Mutations in pancreatic cystic neoplasm [ Time Frame: Baseline ]
    Number and type of mutations that are present on the molecular analysis of premalignant and malignant mucinous cyst.


Secondary Outcome Measures :
  1. Comparison between morphological criteria and cyst fluid analysis [ Time Frame: Baseline ]
    To evaluate the correlation between morphological diagnosis made by endoscopic ultrasound and diagnosis made by cyst fluid analysis (biochemical, cytological and molecular)

  2. Increase power diagnosis with contrast-enhanced EUS [ Time Frame: Baseline ]
    Percentage of pancreatic cyst that can be correctly diagnosed with contrast-enhanced EUS compared to EUS alone

  3. Security of EUS fine-needle aspiration [ Time Frame: 7 days ]
    Number of adverse events that happen during or 7 days after de procedure

  4. Relation between pancreatic fluid and serum molecular analysis [ Time Frame: Baseline ]
    Percentage of mutations that are present in both pancreatic cyst fluid and serum or only in cyst fluid


Biospecimen Retention:   Samples With DNA
Pancreatic cyst fluid and blood samples.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with with an imaging diagnosing pancreatic cystic neoplasm, older than 18 years old, that come to our unit during the 18 months of the study without exclusion criteria.
Criteria

Inclusion Criteria:

  • Indeterminate pancreatic cyst > 2cm
  • Pancreatic cyst > 1cm with morphological diagnosis suspicious to be mucinous etiology
  • Suitable for endoscopy

Exclusion Criteria:

  • Contraindication for endoscopy
  • Active anticoagulant or antiplatelet therapy
  • Thrombocytopenia or coagulopathy in the absence of its correction prior to the procedure
  • Abscence of informed consent
  • Extrapancreatic cyst
  • Known pancreatic pseudocyst

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740360


Contacts
Contact: Raquel F Herranz Pérez 675124482 raquelherranzperez@gmail.com
Contact: HUPrincesa Gastroenterology department +34-91-5202467 cecilio.santander@salud.madrid.org

Locations
Spain
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Contact: Raquel Herranz Pérez    675124482    raquelherranzperez@gmail.com   
Sub-Investigator: Felipe de la Morena         
Sub-Investigator: Cecilio Santander         
Sub-Investigator: Pedro Majano         
Sponsors and Collaborators
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Responsible Party: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
ClinicalTrials.gov Identifier: NCT03740360     History of Changes
Other Study ID Numbers: RHerranz
FdelaMorena ( Other Identifier: HUPrincesa )
CSantander ( Other Identifier: HUPrincesa )
PMajano ( Other Identifier: HUPrincesa )
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundación de Investigación Biomédica - Hospital Universitario de La Princesa:
Pancreatic cystic neoplasm
Molecular analysis
Mucinous cystic neoplasm
Serous cystic neoplasm
Intraductal papillary neoplasm

Additional relevant MeSH terms:
Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases