Clinical trialObsRecruiting
Intraductal Papillary Mucinous Neoplasm (IPMN) Database - A Tool to Predict Pancreatic Cancer
- Outcome
- Ongoing
- Phase
- Obs
- Status
- Recruiting
- Study type
- Observational
- Start
- 26 August 2021
- Expected end
- July 2031
- Enrollment
- 1,000 participants
- Sites
- 1
- Primary outcomes
- The proportion of patients who have progressed to further investigations including endoscopic ultrasound (EUS) and/or surgical intervention.; 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.
- Sponsor
- Other
- Results posted
- No
- Last update
- 18 April 2024
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Brief summary public domain (ClinicalTrials.gov)
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.
Primary outcome public domain (ClinicalTrials.gov)
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 years.
Primary outcome public domain (ClinicalTrials.gov)
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 years.
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 1000 participants (estimated).