Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSt Vincent's Hospital Melbourne
About this trial
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
This trial does not accept healthy volunteersQualifiers
Adult patients between the age of 18 and 90 years old who have been identified with a cystic mass consistent with IPMN on imaging
Disqualifiers
Patients who formally decline enrolment into the study
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention.
Time frame
From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 years2
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.
Time frame
From diagnosis of IPMN followed by clinical follow ups at 3, 6 or 12 monthly interval as specified by clinician, up to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
St Vincent's Hospital Melbourne
Lead sponsor
Epworth Healthcare
Collaborator
Source ClinicalTrials.gov