Long Term Follow up of Small Non-inflammatory Pancreatic Cysts

June 5, 2019 updated by: Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf

Long Term Follow up of Small Non-inflammatory Pancreatic Cysts - a Retrospective Multicenter Study.

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

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • University Hospital Hamburg-Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 18, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKE HH Endoscopy PV3879

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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