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International Registry for Intraductal Papillary Mucinous Neoplasma


2008-03


2019-11-01


2019-11-01


290

Study Overview

International Registry for Intraductal Papillary Mucinous Neoplasma

A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study.

Intraductal papillary mucinous neoplasms of the pancreas (IPMN) are increasingly recognized in clinical practice. They represent a unique clinicopathologic entity that is characterized by mucin production, cystic dilation of the pancreatic ducts, and intraductal papillary growth. The World Health Organization recognized IPMN as a distinct clinical entity in 1996. Recent literature suggests that up to 45% of IPMN are malignant and should be resected; however these data are based on larger, primarily symptomatic lesions. Several studies have been published in the recent literature reporting single-center experience with IPMN resections and observations with small numbers of patients. The natural history of these lesions and risk of malignancy is still vague. Consensus guidelines for management of IPMN were published in 2006, but noted the limited knowledge available in six areas: definition and classification, preoperative evaluation, indication for resection, method of resection, histological data on frozen section/positive margins and specimen processing, and finally, method of follow-up. Speaking to this need, we propose an international registry for multi-center collaboration in the above areas of need in IPMN research and clinical management. This will be through a centralized, web-based registry with data entered by each center in a de-identified way to protect confidentiality. The data collected from the IRB approved retrospective chart review IRB# 07-007202 will be incorporated into this data base. Any patients that participate in the prospective study will be consented with HIPPA consent prior to collection of data.

  • Pancreatic Cysts
    • 07-007845

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates Results Reporting Dates Study Record Updates

    2009-01-21  

    N/A  

    2019-11-04  

    2009-01-22  

    N/A  

    2019-11-06  

    2009-01-23  

    N/A  

    2019-11  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A


    Allocation:
    N/A


    Interventional Model:
    N/A


    Masking:
    N/A


    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    : Pancreatic Cyst

    Pancreatic Cyst

    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Identify clinical and morphological predictors of cancer or high grade dysplasia in patients with IPMN. Identify predictors of progression to cancer or high grade dysplasia among patients who are followed in surveillance programs.Size and growth pattern of pancreas cysts, presence of mural nodules, development of solid tumor or malignancy will be tracked over time, based on imaging studies including EUS, MRI or CT as clinically indicated.End of study
    Secondary Outcome MeasuresMeasure DescriptionTime Frame

    Contacts and Locations

    This section provides the contact details for those conducting the study, and information on where this study is being conducted.

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:
    18 Years

    Accepts Healthy Volunteers:
    1

      Inclusion Criteria:

    • Suspected IPMN based on the consensus guidelines (7)
    • Endoscopic ultrasound imaging at baseline examination
    • Either surgical histology or clinical follow up with EUS, MRI, or CT scan for at least 1 year
    • Cases previously collected that meet the above criteria will be allowed

    • Exclusion Criteria:

    • Patients who do not meet the above inclusion criteria

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.


      • PRINCIPAL_INVESTIGATOR: Michele D Lewis, MD, Mayo Clinic

      Publications

      The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

      General Publications

      No publications available