UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of robot assisted gastrectomy for gastric cancer
Acronym	A phase II study of robot assisted gastrectomy for gastric cancer
Scientific Title	A phase II study of robot assisted gastrectomy for gastric cancer
Scientific Title:Acronym	A phase II study of robot assisted gastrectomy for gastric cancer
Region	Japan

Condition
Condition	Patients with clinical stage I or II gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify safety of robot assisted gastrectomy with lymph node dissection
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Postoperative complications greater than Grade III according to Clavien-Dindo classification
Key secondary outcomes	Completion rate of robot assised surgery The incidence of adverse event Number of dissected lymph nodes Oveall survival Relapse free survival

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Robot assisted surgery
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Biopsy specimen from the primary lesion shows adenocarcinoma 2) Diagnosed as Stage I or II gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography 3) Endoscopic submucosal dissection is not indicated 4) Curative resection is expected by distal gastrectomy or total gastrectomy 5) Eeatern clinical oncology group performans status is 0 or 1 6) Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl
Key exclusion criteria	1) Having other active cancers 2) Possibly pregnant, or breast feeding woman 3) with psychiatric disorder 4) Receiving steroids 5) With Acute myocardial infaction in 6 months or with unstable ungina 6) With uncontrolled hypertention 7) With uncontrolled diabetes mellitus 8) With pulmonary disease and require continuous oxygen therapy
Target sample size	38

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masakazu Yamamoto
Organization	Tokyo Women's Medical University
Division name	Department of Gastroenterological Surgery
Zip code
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL	03-3353-8111
Email	yamamoto@ige.twmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kiyoaki Taniguchi
Organization	Tokyo Women's Medical University
Division name	Department of Gastroenterological Surgery
Zip code
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL	03-3353-8111
Homepage URL
Email	ktaniguchi@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2018 Year 02 Month 09 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	Main results already published
Date of protocol fixation	2018 Year 01 Month 26 Day
Date of IRB	2017 Year 12 Month 01 Day
Anticipated trial start date	2018 Year 01 Month 26 Day
Last follow-up date	2022 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 08 Day
Last modified on	2021 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035619