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Intraductal Papillary Mucinous Neoplasm With Malignant Change

Sponsor
Asan Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02044926
Collaborator
(none)
54
Enrollment
1
Location
30
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Purpose:

To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012.

Hypothesis: According to 2012 consensus guidelines, enhanced solid component and main pancreatic duct size of larger than 10 mm will be significant.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    1. Purpose
    • To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012
    1. Enroll criteria

    • Patient who is suspected to have pancreas IPMN on imaging

    • Interval between imaging study and surgery is less than 2 months

    • Who is scheduled for surgery due to IPMN

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    54 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Intraductal Papillary Mucinous Neoplasm (IPMN) With Malignant Change: Prospective Study to Assess Diagnostic Performance of CT and Magnetic Resonance Imaging (MR) According to International Consensus Guidelines 2012
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    May 1, 2016
    Actual Study Completion Date :
    Jul 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Imaging predictor of malignant IPMN of the pancreas [one month]

      We will assess baseline CT and MRI findings of patients within one month after surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients who is suspected to have IPMN by imaging study or clinician

    • Time interval between imaging study and surgery less than 2 months

    Exclusion Criteria:

    • Patients who have pathology results not by surgery

    • Who is less than 20 years old

    • Who cannot voluntarily agree study design

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    • Principal Investigator: Jae Ho Byun, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jae Ho Byun, Jae Ho Byun, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT02044926
    Other Study ID Numbers:
    • S2013-1472-0002
    First Posted:
    Jan 24, 2014
    Last Update Posted:
    Jul 22, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jul 22, 2016