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

NCT07056972 | Not Yet Recruiting

• 1 other identifier: AOP3688
• Study Type: observational
• Target: 394
• Locations: 0 countries
• Sites: N/A

Brief 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 . 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

Conditions

IPMN; Pancreatic Cancer

Keywords

ipmn; pancreatic cancer; discontinuation of surveillance

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Through study completion at 5 years after inclusion

Secondary Outcomes (12)

• Pancreatic cancer related mortality

  Through study completion at 5 years after inclusion

• All causes mortality

  Through study completion at 5 years after inclusion

• Time to progression or surgery

  Through study completion at 5 years after inclusion

• Incidence of low grade and high grade dysplasia at pathology

  Through study completion at 5 years after inclusion

• Incidence of individual worrisome and high risk features and of individual relative and absolute indications

  Through study completion at 5 years after inclusion

Study Arms (1)

Single-arm, discontinuation of follow-up

Other: Discontinuation of surveillance

Interventions

Discontinuation of surveillance OTHER

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

Single-arm, discontinuation of follow-up

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Oral and written informed consent;
• Age ≥70 years;
• Cyst size ≤30 millimeters.

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 9, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: July 9, 2025

Record last verified: 2025-06