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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000016496
Receipt No. R000019124
Scientific Title A Phase II study of robot assisted laparoscopic distal gastrectomy for clinical stage IA gastric cancer
Date of disclosure of the study information 2015/02/10
Last modified on 2019/08/14

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Basic information
Public title A Phase II study of robot assisted laparoscopic distal gastrectomy for
clinical stage IA gastric cancer
Acronym A Phase II study of robot assisted gastrectomy
Scientific Title A Phase II study of robot assisted laparoscopic distal gastrectomy for
clinical stage IA gastric cancer
Scientific Title:Acronym A Phase II study of robot assisted gastrectomy
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the safety and efficacy of robot assisted laparoscopic distal gastrectomy for cStage IA gastric cancer not applicable for endoscopic submucosal dissection in the introductory period
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidence rate of intra-abdominal complications requiring treatment (postoperative bleeding, anastomotic leakage, intraabdominal abscess, pancreatic fistula)
Key secondary outcomes Overall survival, Relapse-free survival, Completion rate of robot assisted laparoscopic surgery, Proportion of open conversion, Short-term postoperative course

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 Maneuver
Interventions/Control_1 Robot assisted laparoscopic distal gastrectomy
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically proven gastric adenocarcinoma
2) Diagnosed as cStageIA(T1N0) by endoscopy and contrast enhanced CT
3) Not applicable for endoscopic submucosal dissection
4) Regarded as curatively resected by distal gastrectomy with tumor location being M, L, ML, or LM
5) Performance status of 0 or 1
6) Body Mass Index of less than 30
7) No prior surgery in the upper abdomen
8) No prior chemotherapy or radiation therapy for cancers including gastric cancer
9) Informed consent obtained from the patient
Key exclusion criteria 1) Active mutiple primary cancers (carcinoma in situ or mucosal cancer were not included in active cancers)
2) Being pregnant or brestfeeding
3) Continuous steroid use (oral or intravenous)
4) With myocardial infarction in 6 months or with unstable angina
5) With uncontrollable hypertension
6) With uncontrollable diabetes mellitus
7) With respiratory disorder requiring continuous oxgen therapy
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Watanabe
Organization Kitasato University
Division name Department of surgery
Zip code 2520374
Address 1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Email gekaw@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kei
Middle name
Last name Hosoda
Organization Kitasato University
Division name Department of surgery
Zip code 2520374
Address 1-15-1, Kitasato, Sagamihara, Kanagawa, Japan
TEL 042-778-8111
Homepage URL
Email k.hosoda@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Kitasato 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 Research Ethics Committee of the Kitasato University School of Medicine
Address 1-15-1 Kitasato, Sagamihara, Japan
Tel 0427788111
Email rinrib@med.kitasato-u.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
2015 Year 02 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.journalofsurgicalresearch.com/article/S0022-4804(19)30054-X/fulltext
Number of participants that the trial has enrolled 25
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
2015 Year 02 Month 01 Day
Date of IRB
2015 Year 02 Month 13 Day
Anticipated trial start date
2015 Year 02 Month 13 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 09 Day
Last modified on
2019 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019124

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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