International Registry for Intraductal Papillary Mucinous Neoplasma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Cysts

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreatic Cyst

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes