Intraductal Papillary Mucinous Neoplasm With Malignant Change

July 20, 2016 updated by: Jae Ho Byun, Asan Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

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

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

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

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patents who are suspected to have pancreas IPMN by clinicians or imaging studies

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
one month

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Jae Ho Byun, Asan Medical Center

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 Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 21, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 24, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2013-1472-0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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