Immune checkpoint inhibitor-related pancreatic injury (ICI-PI)
Conditions
Interventions
None listed
Sponsors
Kobe University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Case-enriched cohort (multicenter; patients with ICI-PI)] 1. Patients who developed immune checkpoint inhibitor-related pancreatic injury (ICI-PI) after receiving immune checkpoint inhibitors (ICIs) at participating institutions, including collaborating centers, between September 2014 and April 2019 2. Patients whose clinical course and outcome data are available from medical records 3. Patients aged 18 years or older at the start of ICI treatment [Comparative cohort (single-center consecutive cohort; source population for comparative analyses)] 1. Consecutive patients who received immune checkpoint inhibitors (ICIs) at Kobe University Hospital between September 2014 and April 2019 2. Patients whose clinical course and outcome data are available from medical records 3. Patients aged 18 years or older at the start of ICI treatment
Exclusion criteria
Exclusion criteria: Patients who declined participation via the opt-out process following public disclosure of the study information
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pancreatic atrophy and new-onset diabetes or worsening of glucose tolerance in patients with immune checkpoint inhibitor-related pancreatic injury (ICI-PI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of pancreatic calcification and pancreatic exocrine insufficiency Progression-free survival (PFS) Overall survival (OS) | — |
Countries
Japan
Contacts
Public ContactKohei Okamoto
Kobe University Graduate School of Medicine Division of Gastroenterology, Department of Internal Medicine
Outcome results
None listed