UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study on the effect of pancreatectomy in postoperative pancreatic endocrine function
Title of the study (Brief title)	Prospective study of postoperative pancreatic endocrine function
Region	Japan

Condition
Condition	Pancreatic diseases requiring pancreatectomy
Classification by specialty	Endocrinology and Metabolism Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to identify the risk factors for endocrine insufficiency following pancreatectomy with the evaluation of details of changes in endocrine and exocrine function and nutritional states.
Basic objectives2	Others
Basic objectives -Others	epidemiology
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	New-onset diabetes in preoperatively non-diabetic patients and the progression of diabetes in preoperatively diabetic patients within 12 months after surgery
Key secondary outcomes	Oral glucose tolerance tests in before and 1, 3, and 12 months after surgery

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients with pancreatic disease requiring pancreatectomy 2. Performance status (ECOG Eastern Cooperative Oncology Group) 0-1 3. Age is 18 years old or older 4. No metabolic or endocrine disease except type 2 diabetes 5. No advanced malignant disease except pancreatic disease 6. With one's own consent for this study
Key exclusion criteria	Patients whom the principal investigator judges as not eligible
Target sample size	50

Research contact person
Name of lead principal investigator	Hirochika Toyama
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-6302
Email	toyama@med.kobe-u.ac.jp

Public contact
Name of contact person	Hirochika Toyama
Organization	Kobe University Graduate School of Medicine
Division name	Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL	078-382-6302
Homepage URL
Email	toyama@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Graduate School of Medicine Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Institute
Department

Funding Source
Organization	Kobe University Graduate School of Medicine Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	神戸大学医学部付属病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 06 Month 30 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2018 Year 08 Month 01 Day
Date of closure to data entry	2018 Year 08 Month 01 Day
Date trial data considered complete	2018 Year 08 Month 01 Day
Date analysis concluded	2018 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Following data are obtained in before and after surgery: oral glucose tolerance test, serum HbA1c, serum albumin, and body weight.

Management information
Registered date	2012 Year 06 Month 07 Day
Last modified on	2018 Year 12 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009558