Pancreatic CystsNCT01883336
Long Term Follow up of Small Non-inflammatory Pancreatic Cysts
An observational study of Pancreatic Cysts, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pancreatic Cysts
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter
Who cannot join
- acute or chronic pancreatitis
- pancreatic cysts > 3 cm
- Lesion suspicious for malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Pancreatic Cysts
- Keywords
- Incidental pancreatic cysts
- Medical subject headings
- Pancreatic Cyst
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress of pancreatic cyst
To determine the proportion of patients with increase is size and/or changed appearance of pancreatic cyst.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJan 2011
- Primary completionJul 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CystsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Roesch, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883336
- Sponsor's protocol ID
- UKE HH Endoscopy PV3879
- Status last verified
- Mar 2019
- First submitted
- 18 Jun 2013
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of Small Non-inflammatory Pancreatic Cysts - a Retrospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT01883336
- Acronym / sponsor ID
- UKE HH Endoscopy PV3879
- Conditions
- Pancreatic Cysts
- Keywords
- Incidental pancreatic cysts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to investigate the long term follow-up of small non-inflammatory 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).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter
Key exclusion criteria (3 listed)
- acute or chronic pancreatitis
- pancreatic cysts > 3 cm
- Lesion suspicious for malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Roesch, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cysts, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress of pancreatic cyst (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.