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

N/ANot Yet RecruitingNCT07056972

Azienda Ospedaliera di Padova394 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

394

Conditions

IPMN Pancreatic Cancer

Eligibility

Sex: ALLMin age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

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).