UMIN-ICDS Clinical Trial

Public title

Survey of irAE pancreatitis caused by immune checkpoint inhibitors

Acronym

Survey of irAE pancreatitis caused by immune checkpoint inhibitors

Scientific Title

Survey of irAE pancreatitis caused by immune checkpoint inhibitors

Scientific Title:Acronym

Survey of irAE pancreatitis caused by immune checkpoint inhibitors

Region

Japan

Condition

irAE pancreatitis

Classification by specialty

Medicine in general	Hepato-biliary-pancreatic medicine	Hematology and clinical oncology
Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to collect patients with irAE (immune-related Adverse Events: irAE) pancreatitis who developed while receiving ICI (Immune Checkpoint Inhibitor: ICI) or within one year after completing ICI treatment, and to investigate clinicopathological findings, imaging findings, time to disease onset, type and frequency of ICI administration, risk factors, and prognosis. The social significance of this study is to clarify the clinical characteristics of irAE pancreatitis and to establish diagnostic criteria and treatment methods, which will help to ensure the safe use of ICIs and improve treatment outcomes.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of irAE pancreatitis

Key secondary outcomes

Severity of irAE pancreatitis, course of treatment and prognosis, characteristics of blood test data, image findings, and pathological findings

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Between January 1, 2016 and July 1, 2022, patients at participating study sites with ICI (anti-PD-1/PD-L1/CTLA-4 antibodies [nivolumab, ipilimumab, pembrolizumab, atezolizumab, durvalumab, avelumab]) during treatment or within 1 year after completion of treatment. The diagnostic criteria will be patients with the following clinical features (1) to (3), but patients suspected to have irAE pancreatitis by the physician in charge will be widely selected. (1) elevated pancreatic enzymes (Amy>3xULN), (2) abdominal or back pain, (3) findings of acute pancreatitis on imaging studies (pancreatic enlargement or increased peripancreatic fatty tissue density)

Key exclusion criteria

(1) Cases in which pancreatitis is considered to be caused by other factors, (2) patients with insufficient medical information, and (3) patients undergoing clinical trials.

Target sample size

100

Name of lead principal investigator

1st name	Eisuke
Middle name
Last name	Iwasaki

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3790

Email

e-iwa@keio.jp

Name of contact person

1st name	Atsuto
Middle name
Last name	Kayashima

Organization

Keio University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Internal Medicine

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3790

Homepage URL

Email

irae-panc-group@keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Scientific Research on Intractable Diseases, "Research to Establish Diagnostic Criteria and Clinical Practice Guidelines for IgG4-Related Diseases" (Ministry of Health, Labour and Welfare, Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

<Joint research institute>
Division of Hepatobiliary and Pancreas, Department of Surgery, Kinki University School of Medicine
Department of Gastroenterology, Tohoku University Graduate School of Medicine
Kyushu University Graduate School of Oral and Maxillofacial Pathology
Department of Radiology, Kanazawa University Graduate School of Medical Sciences
Department of Pathology, Kurashiki Central Hospital
Laboratory of Molecular Hematopathology, Department of Health Sciences, Okayama University School of Medicine
Department of Gastroenterology, Faculty of Medicine, Tokyo Medical University
Department of General Medical Science, Sapporo Medical University

<Organizations that provide existing samples and information>
Second Department of Internal Medicine, Shinshu University School of Medicine
Department of Gastroenterology, Nagoya University School of Medicine
Department of Gastroenterology, Department of Gastroenterology, Iwate Medical University School of Medicine
Department of Internal Medicine, Faculty of Medicine, Hokkaido University
Third Department of Internal Medicine, Toyama University School of Medicine (Gastroenterology)
Department of Gastroenterology, Kyoto Prefectural University of Medicine
Department of Gastroenterology, Sendai Kosei Hospital
Department of Minimally Invasive Preventive Medicine for Gastrointestinal Diseases, Niigata University School of Medicine
Department of Gastroenterology, Shizuoka Prefectural General Hospital
Department of Gastroenterology, Yamaguchi University Graduate School of Medicine
Department of Gastroenterology, Shiga University of Medical Science
Department of Gastroenterology, Akita University School of Medicine
Department of Gastroenterology, Kanagawa Cancer Center
Department of Gastroenterology, Wakayama Medical University
Department of Gastroenterology, Jichi Medical University School of Medicine
Department of Gastroenterology and Hepatology, Gunma University Graduate School of Medicine
First Department of Gastroenterology, Nagano Red Cross Hospital
Department of Gastroenterology, Fujita Health University School of Medicine
Department of Gastroenterology, Mie University Graduate School of Medicine
Department of Hepato-Biliary-Pancreatic Medicine, Osaka International Cancer Center, Osaka Prefectural Hospital Organization
Third Department of Internal Medicine, Kansai Medical University School of Medicine
Department of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Department of Gastroenterology, Hyogo Cancer Center
Department of Internal Medicine, Shimane University School of Medicine (Internal Medicine II)
Department of Gastroenterology, Kochi University School of Medicine
Kurume University School of Medicine Gastroenterology Center
Department of Gastroenterology, Kanazawa City Hospital
Department of Gastroenterology, Fukushima Medical University School of Medicine
Tohoku Medical and Pharmaceutical University Department of Internal Medicine II (Gastroenterology)

Name of secondary funder(s)

Organization

Ethics Committee, Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

03-5363-3790

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

06

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2022

Year

03

Month

28

Day

Date of IRB

2023

Year

06

Month

06

Day

Anticipated trial start date

2023

Year

06

Month

06

Day

Last follow-up date

2033

Year

04

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Patient Background: Gender, age, and facility.
2. Drugs Used: Immune checkpoint inhibitors administered, and the best response to treatment.
3. Findings at Diagnosis: Date of diagnosis and subjective symptoms reported at diagnosis.
4. Diagnostic Modalities: Imaging modalities and findings, as well as pathology findings.
5. History and Blood Data: Includes WBC (white blood cell count), PLT (platelet count), BUN (blood urea nitrogen), Cr (creatinine), LDH (lactate dehydrogenase), total Ca (calcium), AMY (amylase), P-AMY (pancreatic amylase), lipase, trypsin, CRP (C-reactive protein), BE (base excess), IgG4, and triglycerides. Also includes intensive care unit admission status, presence of complicated organ failure, and exclusion of pancreatitis due to other factors through investigation of the cause.
6. Nature of Complicated irAE: Description of complicated immune-related adverse events at the time of diagnosis and throughout the course of the disease.
7. Treatment: Details of treatment, such as administration of steroids and non-steroidal immunosuppressive drugs. Includes response to immunosuppressive therapy, reduction of amylase level by >50% or within the reference range, imaging improvement, method of reducing steroid/immunosuppressive drug dosage, whether immune checkpoint inhibitor (ICI) was resumed after irAE pancreatitis treatment, and the decision to continue steroids or immunosuppressive drugs.
8. Prognosis: Final outcome, date of confirmation of final outcome, and if applicable, date and cause of death. Indicates whether steroids/immunosuppressive drugs were continued at the time of final outcome confirmation. Also mentions presence or absence of late (after 4 weeks) complications of pancreatitis on follow-up CT and any worsening of irAE pancreatitis during the course.

Images (CT/MRI/ERCP/IDUS/EUS/abdominal US/PET-CT data, etc.) and samples (biopsy specimens, surgical specimens or endoscopically resected material)

Registered date

2023

Year

06

Month

19

Day

Last modified on

2023

Year

12

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058617