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

Official title

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

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

Interventions

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

Primary outcome measures

• Incidence of pancreatic cancer [Time frame: Through study completion at 5 years after inclusion]
• Incidence of futile surgery [Time frame: Through study completion at 5 years after inclusion]

Secondary outcome measures (12)

• 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 [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 [Time frame: At baseline and through study completion at 5 years after inclusion]
• Cyst growth [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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07056972 · AOP3688

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗