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International Registry for Intraductal Papillary Mucinous Neoplasma

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Michele D. Lewis, M.D., Mayo Clinic Identifier:
First received: January 21, 2009
Last updated: January 12, 2016
Last verified: January 2016

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.

Pancreatic Cysts

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: International Registry for Intraductal Papillary Mucinous Neoplasma

Further study details as provided by Michele D. Lewis, M.D., Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 560
Study Start Date: March 2008
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Pancreatic Cyst
Pancreatic Cyst


Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00828048

United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Michele D Lewis, MD Mayo Clinic
  More Information

Responsible Party: Michele D. Lewis, M.D., PI, Mayo Clinic Identifier: NCT00828048     History of Changes
Other Study ID Numbers: 07-007845
Study First Received: January 21, 2009
Last Updated: January 12, 2016

Additional relevant MeSH terms:
Pancreatic Cyst
Pancreatic Diseases
Digestive System Diseases processed this record on August 23, 2017