IPMNNCT02044926
Intraductal Papillary Mucinous Neoplasm With Malignant Change
An observational study of IPMN, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- IPMN
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patents who are suspected to have pancreas IPMN by clinicians or imaging studies
Who may be able to join
- Patients who is suspected to have IPMN by imaging study or clinician
- Time interval between imaging study and surgery less than 2 months
Who cannot join
- Patients who have pathology results not by surgery
- Who is less than 20 years old
- Who cannot voluntarily agree study design
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
- Purpose
- To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012
- 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
- Conditions
- IPMN
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging predictor of malignant IPMN of the pancreas
We will assess baseline CT and MRI findings of patients within one month after surgery.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionJul 2016
Why it stopped: Because patient enrollment is so difficult.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPMNStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Ho Byun, Asan Medical Center
- Investigators
- Jae Ho Byun, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044926
- Sponsor's protocol ID
- S2013-1472-0002
- Status last verified
- Jul 2016
- First submitted
- 21 Jan 2014
- Last updated
- 22 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02044926
- Acronym / sponsor ID
- S2013-1472-0002
- Conditions
- IPMN
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Because patient enrollment is so difficult.
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Purpose
- To investigate diagnostic performance of CT and MR in intraductal papillary mucinous neoplasm with malignant change according to international consensus guidelines 2012
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patents who are suspected to have pancreas IPMN by clinicians or imaging studies
Key inclusion criteria (2 listed)
- Patients who is suspected to have IPMN by imaging study or clinician
- Time interval between imaging study and surgery less than 2 months
Key exclusion criteria (3 listed)
- Patients who have pathology results not by surgery
- Who is less than 20 years old
- Who cannot voluntarily agree study design
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Because patient enrollment is so difficult.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2016.
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The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Ho Byun principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IPMN, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Because patient enrollment is so difficult.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging predictor of malignant IPMN of the pancreas (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.