Clinical trial NCT00828048: International Registry for Intraductal Papillary Mucinous Neoplasma
Official title: International Registry for Intraductal Papillary Mucinous Neoplasma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cysts
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-01-23
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care

Brief summary: A centralized web-based database will be used to track patients with IPMN lesions of the pancreas to study natural history and risk factors for malignant transformation in this multi-center study.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients who do not meet the above inclusion criteria

Primary outcomes:
measure: 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.
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Michele D Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: