NCT06699667

Brief Summary

To retrospectively investigate CT imaging features of autoimmune and chronic pancreatitis (AIP and CP) mimicking pancreatic ductal adenocarcinoma in surgically resected patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

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, 2010

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 21, 2024

Completed
Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

12 years

First QC Date

November 14, 2024

Last Update Submit

November 19, 2024

Conditions

Autoimmune Pancreatitis

Keywords

autoimmune pancreatitispancreatic ductal adenocarcinomaradiology

Outcome Measures

Primary Outcomes (1)

  • 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

    Time frame for each study object is the time between tumor board conference and surgery - typically 2-4 weeks

Interventions

Computed tomographyDIAGNOSTIC_TEST

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General population in Copenhagen

You may qualify if:

  • Definite diagnosis of autoimmune pancreatits or adenocarcinoma

You may not qualify if:

  • No surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autoimmune Pancreatitis

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Pancreatitis, ChronicPancreatitisPancreatic DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Carsten P Hansen, MD

    Department of Surgery and Transplantation, Rigshospitalet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Chief Physician

Study Record Dates

First Submitted

November 14, 2024

First Posted

November 21, 2024

Study Start

January 1, 2010

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

November 21, 2024

Record last verified: 2024-11