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NCT Number: NCT07056972

Surveillance Discontinuation in 5 Year Stable Trivial Branch Duct Intraductal Papillary Mucinous Neoplasms

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

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Key information

Conditions

IPMN Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Personal or familial history of pancreatic cancer;
  • History of pancreatic surgery;
  • Withdrawal of informed consent.

Treatment and study plan

Discontinuation of surveillance

Other

The intervention is discontinuation of current surveillance policies which consist of annual imaging with MRI/MRCP and clinical assessment.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Pancreatic cancer related mortality

    Time frame: Through study completion at 5 years after inclusion

  2. All causes mortality

    Time frame: Through study completion at 5 years after inclusion

  3. Time to progression or surgery

    Time frame: Through study completion at 5 years after inclusion

    in months

  4. Incidence of low grade and high grade dysplasia at pathology

    Time frame: Through study completion at 5 years after inclusion

  5. 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

  6. Incidence of pancreatic surgery

    Time frame: Through study completion at 5 years after inclusion

  7. Serum CA 19.9 value

    Time frame: At baseline and through study completion at 5 years after inclusion

    in U/L

  8. Cyst growth

    Time frame: Through study completion at 5 years after inclusion

    mm/year

  9. Adjusted Charlson comorbidity index (ACCI)

    Time frame: At baseline and through study completion at 5 years after inclusion

  10. Rate of misdiagnosis (only in resected patients) patients)

    Time frame: Through study completion at 5 years after inclusion

  11. Incidence of additional follow up and diagnostic work up

    Time frame: Through study completion at 5 years after inclusion

  12. Incidence of symptoms suspect for PC during follow up

    Time frame: Through study completion at 5 years after inclusion

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Official study title

Surveillance Discontinuation in 5 Year Stable Trivial Branch Duct Intraductal Papillary Mucinous Neoplasms (TRIVIAL): International Prospective Single Arm Multicenter Trial

Acronym: TRIVIAL

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Jul 9, 2025
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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