UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective clinical study of a prophylactic treatment for postgastrectomy pancreatic fistula
Title of the study (Brief title)	A prospective clinical study of a prophylactic treatment for postgastrectomy pancreatic fistula
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	validate a prophylactic use of a fibrin glue sealant according to a prediction of postgastrectomy pancreatic fistula
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postgastrectomy pancreatic fistula
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	using fibrin glue sealant according to a prediction of postgastrectomy pancreatic fistula
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	1) gastric cancer for which distal gastrectomy, proximal gastrectomy, or total gastrectomy with lymph node dissection 2) the ability to undergo anesthesia with an Eastern Cooperative Oncology Group performance status of 0 to 2 3) an age of 20 to 90 years 4) provision of written informed consent
Key exclusion criteria	1) a requirement for pancreatectomy for treatment of pancreatic invasion 2) a requirement for lower mediastinal lymph node dissection or anastomosis in the mediastinal 3) severe injury of other organs 4) inadequacy for patient participation in the study as determined by the investigators
Target sample size	130

Research contact person
Name of lead principal investigator	Kazuyuki Kojima
Organization	Graduate School of Medicine, Tokyo Medical and Dental University
Division name	Minimally Invasive Treatment
Address	Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5260
Email	k-kojima.srg2@tmd.ac.jp

Public contact
Name of contact person	Toshiro Tanioka
Organization	Medical Hospital, Tokyo Medical and Dental University
Division name	Gastric Surgery
Address	Yushima 1-5-45, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-4525
Homepage URL
Email	tanioka.srg1@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 07 Month 03 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 09 Month 04 Day
Last modified on	2018 Year 09 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037942