Autoimmune PancreatitisNCT06699667
CT Findings in Surgically Treated Focal Pancreatic Disease- A Retrospective Study
An observational study of Autoimmune Pancreatitis, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
To retrospectively investigate CT imaging features of autoimmune and chronic pancreatitis (AIP and CP) mimicking pancreatic ductal adenocarcinoma in surgically resected patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Autoimmune Pancreatitis
- What is being tested?
- Computed tomography
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 31 Dec 2021
- 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: General population in Copenhagen
Who may be able to join
- Definite diagnosis of autoimmune pancreatits or adenocarcinoma
Who cannot join
- No surgery
About this study
To retrospectively investigate CT imaging features of autoimmune and chronic pancreatitis (AIP and CP) mimicking pancreatic ductal adenocarcinoma in surgically resected patients.
- Conditions
- Autoimmune Pancreatitis
- Being tested
- Computed tomography
- Keywords
- autoimmune pancreatitis, pancreatic ductal adenocarcinoma, radiology
- Medical subject headings
- Autoimmune Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomographyDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging features of autoimmune pancreatitis
Patients with a final histopathological diagnosis of autoimmune pancreatitis is identified from pancreatic surgery database and compared with matched control groups. Imaging features available at the primary tumor board conference are evaluated blinded to the final diagnosis
Measured: Time frame for each study object is the time between tumor board conference and surgery - typically 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Jan 2010
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune PancreatitisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas S Kristensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Carsten P Hansen, MD, Principal investigator, Department of Surgery and Transplantation, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06699667
- Sponsor's protocol ID
- RH -2015-07, 03616
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Findings in Surgically Treated Focal Pancreatic Disease- A Retrospective Study
- ClinicalTrials.gov ID
- NCT06699667
- Acronym / sponsor ID
- RH -2015-07, 03616
- Conditions
- Autoimmune Pancreatitis
- Keywords
- autoimmune pancreatitis, pancreatic ductal adenocarcinoma, radiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 21 Nov 2024 (actual)
- 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.
To retrospectively investigate CT imaging features of autoimmune and chronic pancreatitis (AIP and CP) mimicking pancreatic ductal adenocarcinoma in surgically resected patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General population in Copenhagen
Key inclusion criteria (1 listed)
- Definite diagnosis of autoimmune pancreatits or adenocarcinoma
Key exclusion criteria (1 listed)
- No surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography | Diagnostic test | – |
Primary outcome
Imaging features of autoimmune pancreatitis
Time frame: Time frame for each study object is the time between tumor board conference and surgery - typically 2-4 weeks
Patients with a final histopathological diagnosis of autoimmune pancreatitis is identified from pancreatic surgery database and compared with matched control groups. Imaging features available at the primary tumor board conference are evaluated blinded to the final diagnosis
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 21 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
Carsten P Hansen, MD principal investigator
Department of Surgery and Transplantation, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Pancreatitis, run by Copenhagen University Hospital, Rigshospitalet.
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 1 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Imaging features of autoimmune pancreatitis (time frame: Time frame for each study object is the time between tumor board conference and surgery - typically 2-4 weeks). 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 21 Nov 2024.