Long Term Follow up of Small Non-inflammatory Pancreatic Cysts

Pancreatic Cysts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883336
• Other study ID #: UKE HH Endoscopy PV3879
• Status: Completed
• Start date: January 2011
• Est. completion date: November 2016

Study information

• Verified date: March 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cysts
• Pancreatic Cyst
• Pancreatic Cysts

Locations

Country	Name	City	State
Germany	University Hospital Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progress of pancreatic cyst	To determine the proportion of patients with increase is size and/or changed appearance of pancreatic cyst.	5 years