UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000019124