UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Prospective, Multi-center Investigation of the performance of Endo GIA Reinforced Reload with Tri-Staple Technology in Gastrectomy for Gastric Cancer
Title of the study (Brief title)	A Prospective, Multi-center Investigation of the performance of Endo GIA Reinforced Reload with Tri-Staple Technology in Gastrectomy for Gastric Cancer
Region	Japan

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

Objectives
Narrative objectives1	The objective of this study is to assess the performance of a surgical stapling device, Endo GIA Reinforced Reload with Tri-Staple Technology, used in gastrectomy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of postoperative duodenal stump leakage
Key secondary outcomes	Staple line hemostasis, any staple malformation, incidence of serosal injury, any additional suturing, amount of blood loss, duration of surgery, incidence of intraoperative and postoperative adverse events, duration of drain placement, duration of hospital stay

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Patients with gastric cancer planned to undergo open or laparoscopic (distal or total) gastrectomy with Roux-en-Y reconstruction using a surgical stapling device 2)Patients aged 20 years or older 3)Patients with no history of upper abdominal surgery (with the exception of laparoscopic cholecystectomy) 4)Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 5)Patients with adequate functions of major organs 6)Patients who have provided written informed consent in person for participation in the study
Key exclusion criteria	1)Women who are pregnant or possibly pregnant, or breastfeeding 2)Patients receiving continuous systemic (oral or intravenous) steroid therapy 3)Patients with concurrent diabetes mellitus with poor control (HbA1c > 8.0%) 4)Patients with a history of allergy to nickel or chrome (a contraindication in IFU) 5)Patients with concurrent mental disorder or psychiatric symptoms judged to preclude participation in this study 6)Other patients judged by the investigator to be inappropriate as a subject of this study
Target sample size	100

Research contact person
Name of lead principal investigator	Kazunari Misawa
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastrointestinal Surgery
Address	1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Prefecture, 464- 8681
TEL	052-762-6111
Email	misawakzn@aichi-cc.jp

Public contact
Name of contact person	Kazunari Misawa
Organization	Aichi Cancer Center Hospital
Division name	Department of Gastrointestinal Surgery
Address	1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Prefecture, 464- 8681
TEL	052-762-6111
Homepage URL
Email	misawakzn@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center Hospital, Department of Gastrointestinal Surgery
Institute
Department

Funding Source
Organization	Covidien Japan Inc.
Organization
Division
Category of Funding Organization	Profit organization
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	愛知県がんセンター中央病院（愛知県） 神奈川県立がんセンター（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 27 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 04 Month 28 Day
Anticipated trial start date	2014 Year 06 Month 30 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	Prospective, multi-center, single-arm, observational registry study

Management information
Registered date	2014 Year 06 Month 27 Day
Last modified on	2017 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016549