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Intraductal Papillary Mucinous Neoplasm With Malignant Change

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ClinicalTrials.gov Identifier: NCT02044926
Recruitment Status : Terminated (Because patient enrollment is so difficult.)
First Posted : January 24, 2014
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Jae Ho Byun, Asan Medical Center

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
IPMN

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
  2. 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

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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 : January 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016



Primary Outcome Measures :
  1. Imaging predictor of malignant IPMN of the pancreas [ Time Frame: one month ]
    We will assess baseline CT and MRI findings of patients within one month after surgery.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patents who are suspected to have pancreas IPMN by clinicians or imaging studies
Criteria

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

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): NCT02044926


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Jae Ho Byun Asan Medical Center
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Responsible Party: Jae Ho Byun, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02044926    
Other Study ID Numbers: S2013-1472-0002
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Neoplasms