UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031204
Receipt No. R000035619
Scientific Title A phase II study of robot assisted gastrectomy for gastric cancer
Date of disclosure of the study information 2018/02/09
Last modified on 2021/02/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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/ctr_e/ctr_view.cgi?recptno=R000035619

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.