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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034366
Receipt No. R000039173
Scientific Title Short- and Long-term outcomes of robotic gastrectomy for gastric cancer: multi-institutional retrospective study
Date of disclosure of the study information 2018/11/01
Last modified on 2019/04/04

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Basic information
Public title Short- and Long-term outcomes of robotic gastrectomy for gastric cancer: multi-institutional retrospective study
Acronym Robotic gastrectomy
Scientific Title Short- and Long-term outcomes of robotic gastrectomy for gastric cancer: multi-institutional retrospective study
Scientific Title:Acronym Robotic gastrectomy
Region
Japan

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

Objectives
Narrative objectives1 To determine the safety, feasibility, and effectiveness of robotic gastrectomy (RG) for gastric cancer (GC) and compare the findings to those of conventional laparoscopic gastrectomy (LG)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 3-year OS
Key secondary outcomes

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 Patients who met the following criteria were included: operable under general anesthesia; histologically proven gastric adenocarcinoma; cStage I or II disease not indicated for endoscopic resection according to the Japanese Gastric Cancer Treatment Guidelines; curably treated with total, distal, or proximal gastrectomy involving D1+ or D2 lymph node dissection; age over 18 years.
Key exclusion criteria Patients who met the following criteria were excluded: preoperative use of chemotherapy and presence of mental disorders.
Target sample size 1127

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Uyama
Organization Fujita Health University
Division name Gastroenterological Surgery
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL 0562-93-9254
Email iuyama@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Suda
Middle name
Last name Koichi
Organization Fujita Health University
Division name Gastroenterological Surgery
Zip code 470-1192
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL 0562-93-9254
Homepage URL
Email ko-suda@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Saga University, Kyoto University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Fujita Health University
Address 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel 0562-93-2865
Email f-irb@fujita-hu.ac.jp

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 11 Month 01 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 1127
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 No longer recruiting
Date of protocol fixation
2018 Year 09 Month 28 Day
Date of IRB
2018 Year 12 Month 25 Day
Anticipated trial start date
2018 Year 12 Month 26 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Short- and Long-term outcomes will be compared between the 326 patients who underwent robotic gastrectomy in the UMIN000015388 study and the 801 patients who underwent conventional laparoscopic gastrectomy (the historical control group in the UMIN00001538 study).

Management information
Registered date
2018 Year 10 Month 03 Day
Last modified on
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039173

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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