Clinical trial NCT05117723: Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer
Official title: Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IPMN, Pancreatic
IPMN
Keywords: pancreatic cyst
Lead sponsor: St Vincent's Hospital Melbourne
Sponsor class: OTHER
Collaborators: name: Epworth Healthcare
First posted: 2021-11-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with IPMN will be identified from consultations at each hospital site with surgical and medical specialists with an interest in pancreatic conditions. This will occur via consultations conducted in public clinic settings and from private consultations and multi-disciplinary meetings.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention.
timeFrame: From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years
measure: 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.
timeFrame: From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
Study officials:
affiliation: St Vincent's Hospital Melbourne
name: Adrian Fox
role: PRINCIPAL_INVESTIGATOR
References: