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

Recruiting

• Conditions: IPMN; IPMN, Pancreatic

• Registration Number: NCT05117723
• Lead Sponsor: St Vincent's Hospital Melbourne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-26
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2031-07
• Study Completion: 2031-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St Vincent's Hospital Melbourne; 🇦🇺 Fitzroy, Victoria, Australia