Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer

NCT05117723 — Recruiting, 1000 participants, St Vincent's Hospital Melbourne
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RegistryNCT05117723, acronym MAPS
StatusRecruiting
Study typeObservational
Enrollment1000 (Estimated)
SponsorSt Vincent's Hospital Melbourne (Other); collaborators: Epworth Healthcare
ConditionsIPMN, Pancreatic, IPMN
Datesstart 2021-08-26, primary completion 2031-07-01 (estimated), completion 2031-07-01 (estimated), first posted 2021-11-11, last updated 2024-04-18
Locations1 site in Australia

Related Papers Related Patents Related Grants Related Experts
All trials for IPMN, Pancreatic All trials for IPMN

-Summary

Pancreatic cancer is the 5th leading cause of cancer death in Australia. Surgery remains the most effective treatment for early pancreatic cancer and currently the only potential for cure. Unfortunately, many patients present with advanced disease and are not suitable for surgery. Therefore, it is vital to detect these cancers early. In the absence of significant data from prospective studies, all of the guidelines are based on a critical review of available data and consensus of experts. The primary aim is to delineate the progression of IPMN to pancreatic malignancy as confirmed by surgical pathology, radiology and biochemical diagnosis. The secondary aims are (i) To outline the management of IPMNs for those who have progressed straight to surgery or surveillance by endoscopic ultrasound (EUS) (ii)To validate the International consensus guidelines for management of IPMN - Fukuoka consensus guidelines and tertiary aim to identify potential risk factors, if any that increase risk of malignancy within the IPMNs.

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+Outcome measures

Primary outcomes

  • The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention. [From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years]
  • Risk stratification for patients with IPMN into those that require more intensive screening and possibly intervention versus those that are unlikely to progress to malignancy. [From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years]

+Eligibility

Sex: All, ages: 18 Years to 90 Years

Inclusion Criteria:

* Adult patients between the age of 18 and 90 years old who have been identified with a cystic mass consistent with IPMN on imaging

Exclusion Criteria:

* Patients who formally decline enrolment into the study

+Locations (1)

FacilityCityCountryStatus
St Vincent's Hospital MelbourneFitzroy, VictoriaAustraliaRecruiting

+Investigators

  • Adrian Fox, Principal investigator, St Vincent's Hospital Melbourne