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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 : Completed
First Posted : November 14, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Tracking Information
First Submitted Date October 14, 2018
First Posted Date November 14, 2018
Last Update Posted Date February 21, 2020
Actual Study Start Date June 1, 2017
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 13, 2018)
  • 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)
  • 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
  • Security of EUS fine-needle aspiration [ Time Frame: 7 days ]
    Number of adverse events that happen during or 7 days after de procedure
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Contrast Enhanced Ultrasound and Molecular Analysis in the Diagnosis of Pancreatic Cyst
Official Title Prospective Analysis About the Utility of Contrast Enhanced Endoscopic Ultrasound and Molecular Analysis in the Study of Pancreatic Cyst
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.
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]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Retention:   Samples With DNA
Description:
Pancreatic cyst fluid and blood samples.
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.
Condition Pancreatic Cyst
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 20, 2020)
36
Original Estimated Enrollment
 (submitted: November 13, 2018)
32
Actual Study Completion Date October 31, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03740360
Other Study ID Numbers RHerranz
FdelaMorena ( Other Identifier: HUPrincesa )
CSantander ( Other Identifier: HUPrincesa )
PMajano ( Other Identifier: HUPrincesa )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Study Sponsor Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborators Not Provided
Investigators Not Provided
PRS Account Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Verification Date February 2020