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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Pancreatic cancer related mortality [Срок оценки: Through study completion at 5 years after inclusion]
• All causes mortality [Срок оценки: Through study completion at 5 years after inclusion]
• Time to progression or surgery [Срок оценки: Through study completion at 5 years after inclusion]
• Incidence of low grade and high grade dysplasia at pathology [Срок оценки: Through study completion at 5 years after inclusion]
• Incidence of individual worrisome and high risk features and of individual relative and absolute indications [Срок оценки: Through study completion at 5 years after inclusion]
• Incidence of pancreatic surgery [Срок оценки: Through study completion at 5 years after inclusion]
• Serum CA 19.9 value [Срок оценки: At baseline and through study completion at 5 years after inclusion]
• Cyst growth [Срок оценки: Through study completion at 5 years after inclusion]
• Adjusted Charlson comorbidity index (ACCI) [Срок оценки: At baseline and through study completion at 5 years after inclusion]
• Rate of misdiagnosis (only in resected patients) patients) [Срок оценки: Through study completion at 5 years after inclusion]
• Incidence of additional follow up and diagnostic work up [Срок оценки: Through study completion at 5 years after inclusion]
• Incidence of symptoms suspect for PC during follow up [Срок оценки: Through study completion at 5 years after inclusion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07056972 · AOP3688

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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