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

Study Overview

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

N/A

IPMN
Pancreatic Cancer

OTHER: Discontinuation of surveillance

AOP3688

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-06-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-06
First Submitted that Met QC Criteria 2025-07-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-09
First Posted (ACTUAL) 2025-07-09	Results First Posted N/A	Last Verified 2025-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Single-arm, discontinuation of follow-up	OTHER: Discontinuation of surveillance The intervention is discontinuation of current surveillance policies which consist of annual imaging with MRI/MRCP and clinical assessment.

Participant Group/Arm

Intervention/Treatment

: Single-arm, discontinuation of follow-up

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	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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	in months	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
Incidence of pancreatic surgery		Through study completion at 5 years after inclusion
Serum CA 19.9 value	in U/L	At baseline and through study completion at 5 years after inclusion
Cyst growth	mm/year	Through study completion at 5 years after inclusion
Adjusted Charlson comorbidity index (ACCI)		At baseline and through study completion at 5 years after inclusion
Rate of misdiagnosis (only in resected patients) patients)		Through study completion at 5 years after inclusion
Incidence of additional follow up and diagnostic work up		Through study completion at 5 years after inclusion
Incidence of symptoms suspect for PC during follow up		Through study completion at 5 years after inclusion

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
70 Years

Accepts Healthy Volunteers:
1

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record