NCT02044926

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 22, 2016

Status Verified

July 1, 2016

Enrollment Period

2.3 years

First QC Date

January 21, 2014

Last Update Submit

July 20, 2016

Conditions

IPMN

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients who is suspected to have IPMN by imaging study or clinician
  • Time interval between imaging study and surgery less than 2 months

You may not qualify if:

  • Patients who have pathology results not by surgery
  • Who is less than 20 years old
  • Who cannot voluntarily agree study design

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Officials

  • Jae Ho Byun

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jae Ho Byun

Study Record Dates

First Submitted

January 21, 2014

First Posted

January 24, 2014

Study Start

January 1, 2014

Primary Completion

May 1, 2016

Study Completion

July 1, 2016

Last Updated

July 22, 2016

Record last verified: 2016-07

Locations

KR(1)