NCT01883336

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

June 6, 2019

Status Verified

March 1, 2019

Enrollment Period

5.5 years

First QC Date

June 18, 2013

Last Update Submit

June 5, 2019

Conditions

Keywords

Incidental pancreatic cysts

Outcome Measures

Primary Outcomes (1)

  • Progress of pancreatic cyst

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

    5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Thomas Roesch, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Thomas Roesch, Universitätsklinikum Hamburg Eppendorf, Endoscopy department

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 21, 2013

Study Start

January 1, 2011

Primary Completion

July 1, 2016

Study Completion

November 1, 2016

Last Updated

June 6, 2019

Record last verified: 2019-03

Locations