International Registry for Intraductal Papillary Mucinous Neoplasma
This trial is active, not recruiting.
|Start date||March 2008|
|End date||January 2017|
|Trial size||560 participants|
|Trial identifier||NCT00828048, 07-007845|
Intraductal papillary mucinous neoplasms of the pancreas (IPMN) are increasingly recognized in clinical practice. They represent a unique clinicopathologic entity that is characterized by mucin production, cystic dilation of the pancreatic ducts, and intraductal papillary growth. The World Health Organization recognized IPMN as a distinct clinical entity in 1996. Recent literature suggests that up to 45% of IPMN are malignant and should be resected; however these data are based on larger, primarily symptomatic lesions. Several studies have been published in the recent literature reporting single-center experience with IPMN resections and observations with small numbers of patients. The natural history of these lesions and risk of malignancy is still vague. Consensus guidelines for management of IPMN were published in 2006, but noted the limited knowledge available in six areas: definition and classification, preoperative evaluation, indication for resection, method of resection, histological data on frozen section/positive margins and specimen processing, and finally, method of follow-up. Speaking to this need, we propose an international registry for multi-center collaboration in the above areas of need in IPMN research and clinical management. This will be through a centralized, web-based registry with data entered by each center in a de-identified way to protect confidentiality.
The data collected from the IRB approved retrospective chart review IRB# 07-007202 will be incorporated into this data base. Any patients that participate in the prospective study will be consented with HIPPA consent prior to collection of data.
|Observational model||case control|
Identify clinical and morphological predictors of cancer or high grade dysplasia in patients with IPMN. Identify predictors of progression to cancer or high grade dysplasia among patients who are followed in surveillance programs.
time frame: End of study
We plan to pilot test the database at the host site MCJ, then roll-out to the remaining external sites.
time frame: End of study
Male or female participants from 18 years up to 99 years old.
- Suspected IPMN based on the consensus guidelines (7)
- Endoscopic ultrasound imaging at baseline examination
- Either surgical histology or clinical follow up with EUS, MRI, or CT scan for at least 1 year
- Cases previously collected that meet the above criteria will be allowed
- Patients who do not meet the above inclusion criteria
|Official title||International Registry for Intraductal Papillary Mucinous Neoplasma|
|Principal investigator||Michele D Lewis, MD|
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