IPMNTRIVIALNCT07056972
Surveillance Discontinuation in 5 Year Stable Trivial Branch Duct Intraductal Papillary Mucinous Neoplasms
An observational study of IPMN and Pancreatic Cancer, run by Azienda Ospedaliera di Padova.
Trial summary
BACKGROUND: Patients with trivial branch duct intraductal papillary mucinous neoplasm (BD IPMN) which remain s stable over 5 years reportedly do not have an increased risk of developing pancreatic cancer (PC) compared to the general population. In these patients, d iscontinuation of surveillance seems feasible . Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- IPMN, Pancreatic Cancer
- What is being tested?
- Discontinuation of surveillance
- How many people
- 394 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: All consecutive patients of ≥70 years of age with trivial BD IPMN ≤30 millimeters that have been stable for at least 5 years are eligible for inclusion.
Who may be able to join
- Oral and written informed consent;
- Age ≥70 years;
- BD IPMN with ≥1 dilated branch duct(s) communicating with a nondilated main pancreatic duct (≤5 millimeter) as seen on Magnetic Resonance Cholangio-Pancreatography (MRCP), performed within the last 3 months prior to inclusion;
- At least 5 years of follow up prior to inclusion;
- Absence of relative and absolute indications for surgery at diagnosis and inclusion according to European guidelines;
- Absence of worrisome features and/or high risk stigmata at diagnosis and inclusion according to IAP guidelines;
- Cyst size ≤30 millimeters.
Who cannot join
- Personal or familial history of pancreatic cancer;
- History of pancreatic surgery;
- Withdrawal of informed consent.
About this study
Official title: Surveillance Discontinuation in 5 Year Stable Trivial Branch Duct Intraductal Papillary Mucinous Neoplasms (TRIVIAL): International Prospective Single Arm Multicenter Trial
BACKGROUND: Patients with trivial branch duct intraductal papillary mucinous neoplasm (BD IPMN) which remain s stable over 5 years reportedly do not have an increased risk of developing pancreatic cancer (PC) compared to the general population. In these patients, d iscontinuation of surveillance seems feasible . However, prospective studies to confirm the safety of this approach are lacking.
AIM: To assess whether current surveillance policies for stable, trivial BD IPMN can be discontinued safely after 5 years of follow up .
Read more
METHODS: TRIVIAL is an international prospective multicenter single arm trial exploring discontinuation of surveillance in patients with at least 5 years stable trivial BD IPMN. The trial will include 394 adult patients at least 70 years of age with BD IPMN ≤ 30 millimeter without worrisome features or high risk stigmata during 5 years. The primary endpoint is rate of PC and futile surgery (i.e., surgery for low grade dysplasia IPMN or other non malignant pathology) during 5 year follow up. The predefined target is a rate of 1% and below 3%.
STRENGTHS: The burden for patients to participate in this trial is negligible. P atients will only be asked to answer self reported digital surveys once per year during five years . The potential benefits for patients are twofold: the psychological impact of potentially unnecessary surveillance will be spared to patients , whereas the socio economic burden of repeated imaging will be avoided. Moreover, the study will provide data contributing to the development of new, evidence based surveillance strateg ies At the end of follow up patients undergo MRCP to assess disease course (i.e., development of worrisome features, high risk stigmata, PC).
LIMITATIONS: The most prominent risk of IPMN is the development of pancreatic cancer However this risk will not be omitted fully by the TRIVIAL trial eligibility criteria as participants still have the same risk as the general population. This requires adequate counselling
- Conditions
- IPMN, Pancreatic Cancer
- Being tested
- Discontinuation of surveillance
- Keywords
- ipmn, pancreatic cancer, discontinuation of surveillance
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of surveillanceOther
The intervention is discontinuation of current surveillance policies which consist of annual imaging with MRI/MRCP and clinical assessment.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm, discontinuation of follow-up | Not described Receives: Other: Discontinuation of surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pancreatic cancer
Primary endpoint is pancreatic cancer (PC), including IPMN derived PC high grade dysplasia (HGD) or concurrent PC, confirmed by pathology (e.g., surgery, fine needle biopsy), at 5 years follow up.
Concurrent PC is defined as invasive PC that develops independently from the associated IPMN with a non dilated , segment of the pancreatic duct present between the two lesions. Therefore, a clear distinction will be made on what type of PC occurred (i.e., IPMN derived, HGD, concurrent PC).
Measured: Through study completion at 5 years after inclusion
Incidence of futile surgery
Futile surgery is defined as surgery for IPMN with low grade dysplasia (LGD) confirmed at final pathology, or other non malignant diagnosis (i.e., pseudocysts , serous cystadenoma).
Measured: Through study completion at 5 years after inclusion
Secondary outcomes (12)
Pancreatic cancer related mortality
Measured: Through study completion at 5 years after inclusion
All causes mortality
Measured: Through study completion at 5 years after inclusion
Time to progression or surgery
in months
Measured: Through study completion at 5 years after inclusion
Incidence of low grade and high grade dysplasia at pathology
Measured: Through study completion at 5 years after inclusion
Incidence of individual worrisome and high risk features and of individual relative and absolute indications
Measured: Through study completion at 5 years after inclusion
Incidence of pancreatic surgery
Measured: Through study completion at 5 years after inclusion
Serum CA 19.9 value
in U/L
Measured: At baseline and through study completion at 5 years after inclusion
Cyst growth
mm/year
Measured: Through study completion at 5 years after inclusion
Adjusted Charlson comorbidity index (ACCI)
Measured: At baseline and through study completion at 5 years after inclusion
Rate of misdiagnosis (only in resected patients) patients)
Measured: Through study completion at 5 years after inclusion
Incidence of additional follow up and diagnostic work up
Measured: Through study completion at 5 years after inclusion
Incidence of symptoms suspect for PC during follow up
Measured: Through study completion at 5 years after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
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.
- 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
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Umberto Cillo, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056972
- Sponsor's protocol ID
- AOP3688
- Acronym
- TRIVIAL
- Status last verified
- Jun 2025
- First submitted
- 26 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Discontinuation in 5 Year Stable Trivial Branch Duct Intraductal Papillary Mucinous Neoplasms (TRIVIAL): International Prospective Single Arm Multicenter Trial
- ClinicalTrials.gov ID
- NCT07056972
- Acronym / sponsor ID
- TRIVIAL / AOP3688
- Conditions
- IPMN, Pancreatic Cancer
- Keywords
- ipmn, pancreatic cancer, discontinuation of surveillance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 9 Jul 2025 (actual)
- 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.
BACKGROUND: Patients with trivial branch duct intraductal papillary mucinous neoplasm (BD IPMN) which remain s stable over 5 years reportedly do not have an increased risk of developing pancreatic cancer (PC) compared to the general population. In these patients, d iscontinuation of surveillance seems feasible . However, prospective studies to confirm the safety of this approach are lacking.
AIM: To assess whether current surveillance policies for stable, trivial BD IPMN can be discontinued safely after 5 years of follow up .
METHODS: TRIVIAL is an international prospective multicenter single arm trial exploring discontinuation of surveillance in patients with at least 5 years stable trivial BD IPMN. The trial will include 394 adult patients at least 70 years of age with BD IPMN ≤ 30 millimeter without worrisome features or high risk stigmata during 5 years. The primary endpoint is rate of PC and futile surgery (i.e., surgery for low grade dysplasia IPMN or other non malignant pathology) during 5 year follow up. The predefined target is a rate of 1% and below 3%.
STRENGTHS: The burden for patients to participate in this trial is negligible. P atients will only be asked to answer self reported digital surveys once per year during five years . The potential benefits for patients are twofold: the psychological impact of potentially unnecessary surveillance will be spared to patients , whereas the socio economic burden of repeated imaging will be avoided. Moreover, the study will provide data contributing to the development of new, evidence based surveillance strateg ies At the end of follow up patients undergo MRCP to assess disease course (i.e., development of worrisome features, high risk stigmata, PC).
LIMITATIONS: The most prominent risk of IPMN is the development of pancreatic cancer However this risk will not be omitted fully by the TRIVIAL trial eligibility criteria as participants still have the same risk as the general population. This requires adequate counselling
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm, discontinuation of follow-up | – | Other: Discontinuation of surveillance |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- All consecutive patients of ≥70 years of age with trivial BD IPMN ≤30 millimeters that have been stable for at least 5 years are eligible for inclusion.
Key inclusion criteria (7 listed)
- Oral and written informed consent;
- Age ≥70 years;
- BD IPMN with ≥1 dilated branch duct(s) communicating with a nondilated main pancreatic duct (≤5 millimeter) as seen on Magnetic Resonance Cholangio-Pancreatography (MRCP), performed within the last 3 months prior to inclusion;
- At least 5 years of follow up prior to inclusion;
- Absence of relative and absolute indications for surgery at diagnosis and inclusion according to European guidelines;
Key exclusion criteria (3 listed)
- Personal or familial history of pancreatic cancer;
- History of pancreatic surgery;
- Withdrawal of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Discontinuation of surveillanceThe intervention is discontinuation of current surveillance policies which consist of annual imaging with MRI/MRCP and clinical assessment. | Other | Single-arm, discontinuation of follow-up |
Primary outcome
Incidence of pancreatic cancer
Time frame: Through study completion at 5 years after inclusion
Primary endpoint is pancreatic cancer (PC), including IPMN derived PC high grade dysplasia (HGD) or concurrent PC, confirmed by pathology (e.g., surgery, fine needle biopsy), at 5 years follow up. Concurrent PC is defined as invasive PC that develops independently from the associated IPMN with a non dilated , segment of the pancreatic duct present between the two lesions. Therefore, a clear distinction will be made on what type of PC occurred (i.e., IPMN derived, HGD, concurrent PC).
Incidence of futile surgery
Time frame: Through study completion at 5 years after inclusion
Futile surgery is defined as surgery for IPMN with low grade dysplasia (LGD) confirmed at final pathology, or other non malignant diagnosis (i.e., pseudocysts , serous cystadenoma).
12 secondary outcomes
Pancreatic cancer related mortality
Time frame: Through study completion at 5 years after inclusion
All causes mortality
Time frame: Through study completion at 5 years after inclusion
Time to progression or surgery
Time frame: Through study completion at 5 years after inclusion
Incidence of low grade and high grade dysplasia at pathology
Time frame: Through study completion at 5 years after inclusion
Incidence of individual worrisome and high risk features and of individual relative and absolute indications
Time frame: Through study completion at 5 years after inclusion
Incidence of pancreatic surgery
Time frame: Through study completion at 5 years after inclusion
Serum CA 19.9 value
Time frame: At baseline and through study completion at 5 years after inclusion
Cyst growth
Time frame: Through study completion at 5 years after inclusion
Adjusted Charlson comorbidity index (ACCI)
Time frame: At baseline and through study completion at 5 years after inclusion
Rate of misdiagnosis (only in resected patients) patients)
Time frame: Through study completion at 5 years after inclusion
Incidence of additional follow up and diagnostic work up
Time frame: Through study completion at 5 years after inclusion
Incidence of symptoms suspect for PC during follow up
Time frame: Through study completion at 5 years after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of IPMN and Pancreatic Cancer, run by Azienda Ospedaliera di Padova.
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 7 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: opening soon, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of pancreatic cancer (time frame: Through study completion at 5 years after inclusion). The study lists 2 primary outcomes in all. 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 9 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.