UMIN-CTR Clinical Trial

Basic information
Public title	The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer -Single institute prospective cohort study
Acronym	The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer
Scientific Title	The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer -Single institute prospective cohort study
Scientific Title:Acronym	The feasibility study of Robot-assisted gastrectomy for patients with gastric cancer
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of feasibility of robot-assisted surgery for gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incident of postoperative complications beyond Clavien-Dindo IIIa.
Key secondary outcomes	1. All adverse events 2. Number of lymph node dissection 3. Surgical time (anesthesia time, operation time, console operation time, total time from entering operation room to leaving) 4. Bleeding volume 5. Intraoperative incident 6. Proportion of conversion to open surgery 7. Period up to the start of postoperative adjuvant chemotherapy 8. Hospitalization days 9. Cost

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients where a distal , pylorus preserving, proximal or total gastrectomy was planned, following by histologically confirmed gastric cancer (common type: pap, tub 1, tub 2, por 1, por 2, sig, muc) before surgery. 2. Patients of c Stage I gastric cancer (T1N0M0, T2N0M0, T1N1M0)
Key exclusion criteria	1. Patients with remnant stomach cancer. 2. Patients who underwent radiotherapy or other cancer treatment before surgery. 3. Patients who are required comprehensive resection of the spleen or other organs. 4. Patients who undergo large invasive surgery such as colon cancer surgery. 5. Patients who cannot obtain informed consent to participate in this study. 6. Patients with esophageal invasion 7. Patients with duodenal invasion
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Michitaka Honda
Organization	Southern Tohoku General Hospital
Division name	Surgery
Zip code
Address	Yatsuyamada 7-115, Koriyama, Fukushima
TEL	024-934-5322
Email	mhonda@fukushimamed.com

Public contact
Name of contact person	1st name Middle name Last name Michitaka Honda
Organization	Southern Tohoku General Hospital
Division name	Surgery
Zip code
Address	Yatsuyamada 7-161, Koriyama, Fukushima
TEL	024-934-5322
Homepage URL
Email	mhonda@fukushimamed.com

Sponsor
Institute	Southern Tohoku General Hospital
Institute
Department

Funding Source
Organization	Southern Tohoku General Hospital
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	一般財団法人脳神経疾患研究所　総合南東北病院（福島県）

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 06 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	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Evaluation of feasibility of robot-assisted surgery for gastric cancer

Management information
Registered date	2019 Year 01 Month 06 Day
Last modified on	2021 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040398