An observational study in IPMN and Pancreatic Cancer, sponsored by Azienda Ospedaliera di Padova. Not yet recruiting. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Azienda Ospedaliera di Padova · Observational
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
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's planned enrollment of 394 is above the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Azienda Ospedaliera di Padova is the lead sponsor of 38 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Discontinuation of surveillance
The intervention is discontinuation of current surveillance policies which consist of annual imaging with MRI/MRCP and clinical assessment.
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).
Time frame: 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).
Time frame: Through study completion at 5 years after inclusion
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
in months
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
in U/L
Time frame: At baseline and through study completion at 5 years after inclusion
Cyst growth
mm/year
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
No study locations are listed for this record.
Start is estimated for Jul 2025; primary completion for Jul 2031, 72 months later.
Of 318 non-industry observational studies under Pancreatic Neoplasms, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 182. This study's planned 72 months is close to that.
Counting every sponsor, half of 352 studies reached it within 60 months; a quarter within 34 and three quarters within 182.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Azienda Ospedaliera di Padova