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

ConditionsIPMN Pancreatic Cancer

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age70+

SponsorAzienda Ospedaliera di Padova

About this 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 .

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

Personal or familial history of pancreatic cancer;

History of pancreatic surgery;

Withdrawal of informed consent.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

394 Participants

are divided into 1 treatment group

Group A: Single-arm, discontinuation of follow-up1 intervention

Trial outcomes

Primary outcomes

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