UMIN-CTR Clinical Trial

Basic information
Public title	An observation study of pancreatic endocrine secretion after glucagon infusion on the patients that were operated with a subtotal pancreatectomy
Acronym	An observation study of pancreatic endocrine secretion on the patients after tumor removal by subtotal pancreatectomy
Scientific Title	An observation study of pancreatic endocrine secretion after glucagon infusion on the patients that were operated with a subtotal pancreatectomy
Scientific Title:Acronym	An observation study of pancreatic endocrine secretion on the patients after tumor removal by subtotal pancreatectomy
Region	Japan

Condition
Condition	Pancreatic biliary tract disease including malignant disorders is planned a subtotal pancreatectomy
Classification by specialty	Endocrinology and Metabolism Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	An observation study of endocrine pancreatic endocrine secretion after glucagon injection on the patients, have pancreatic biliary disease including malignant disorders, were operated with a subtotal pancreatectomy
Basic objectives2	Others
Basic objectives -Others	Labolatory parameter
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Delta C-peptide in glucagon injection. (delta C-peptide = max C-peptide - base C-peptide) Observation of the mean of delta C-peptide from before to the end of study.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	(a) Patients were underwent subtotal pancreatectomy. (b) Patients are outpatients or inpatients (c) Patients need anti-diabetic agents after subtotal pancreatectomy. (d) Patients with a therapy of diabetes mellitus before subtotal pancreatectomy.
Key exclusion criteria	(a) Patients with a history of total pancreatectomy. (b) Patients with insulin-dependent diabetes mellitus.(Fatigue serum C-peptide under 0.5 ng/ml or 24hr C-peptide under 20 microg/day) (c) Patients with a history of severe cardiovascular or cerebrovascular disease or renal failure. (d) Patients have contraindication of glucagon. (e) Patients with severe liver damage. (f) Patients are pregnant or patients breast-feeding, potentially pregnant. (g) Patients who are diagnosed to be ineligible by the investigator.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shuhei Nakanishi
Organization	Hiroshima University Hospital
Division name	Department of Endocrinology and Diabetes mellitus
Zip code
Address	1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL	082-257-5198
Email

Public contact
Name of contact person	1st name Middle name Last name Tsuguka Shiwa
Organization	Hiroshima University Hospital
Division name	Department of Endocrinology and Diabetes mellitus
Zip code
Address	1-2-3, Kasumi, Minami-ku, Hiroshima-City, Hiroshima 734-8551, Japan
TEL	082-257-5198
Homepage URL
Email	tsuguka@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University Hospital Department of Endocrinology and Diabetes mellitus
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 11 Month 08 Day
Date of IRB	2010 Year 11 Month 01 Day
Anticipated trial start date	2010 Year 11 Month 01 Day
Last follow-up date	2019 Year 07 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective study about the pancreatic endocrine secretion in a patient after subtotal pancreatectomy

Management information
Registered date	2010 Year 12 Month 01 Day
Last modified on	2019 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005138