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Long Term Follow up of Small Non-inflammatory Pancreatic Cysts

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01883336
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts.

Condition or disease
Pancreatic Cysts

Detailed Description:

This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts in a multicenter setting.

Inclusion criteria:

Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter referred to the University Hospital Hamburg Eppendorf, Israelitic Hospital Hamburg, Sana Klinikum Lichtenberg, Berlin and Krankenhaus Märkisch-Oderland,Strausberg from 2002 to 2007 identified from EUS database.

Study design:

At least 5 year-long term follow up by inclusion of clinical data, cross sectional imaging if available or actual US findings.

Primary outcome:

To determine the proportion of patients with increase is size and/or changed appearance

Secondary outcomes:

Rate of patients undergo pancreatic surgery (indication, histology of resected specimen). Rate of patients undergo FNA (fluid analysis, cytology).

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Long Term Follow up of Small Non-inflammatory Pancreatic Cysts - a Retrospective Multicenter Study.
Actual Study Start Date : January 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : November 2016



Primary Outcome Measures :
  1. Progress of pancreatic cyst [ Time Frame: 5 years ]
    To determine the proportion of patients with increase is size and/or changed appearance of pancreatic cyst.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter referred to the University Hospital Hamburg Eppendorf, Israelitic Hospital Hamburg, Sana Klinikum Lichtenberg, Berlin and Krankenhaus Märkisch-Oderland,Strausberg.
Criteria

Inclusion Criteria:

  • Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter

Exclusion Criteria:

  • acute or chronic pancreatitis
  • pancreatic cysts > 3 cm
  • Lesion suspicious for malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883336


Locations
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Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Thomas Roesch, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf
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Responsible Party: Prof. Dr. Thomas Rösch, Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg Eppendorf, Endoscopy department, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01883336    
Other Study ID Numbers: UKE HH Endoscopy PV3879
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: March 2019
Keywords provided by Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf:
Incidental pancreatic cysts
Additional relevant MeSH terms:
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Cysts
Pancreatic Cyst
Neoplasms
Pathological Conditions, Anatomical
Pancreatic Diseases
Digestive System Diseases