Intraductal Papillary Mucinous Neoplasm With Malignant Change

IPMN Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02044926
• Other study ID #: S2013-1472-0002
• Status: Terminated
• Phase: N/A
• First received: January 21, 2014
• Last updated: July 20, 2016
• Start date: January 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 54
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• IPMN
• Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging predictor of malignant IPMN of the pancreas	We will assess baseline CT and MRI findings of patients within one month after surgery.	one month	No