UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of robot assisted gastrectomy with nodal dissection for clinical stage I gastric cancer using the da Vinci Si surgical system
Title of the study (Brief title)	Lap-G da Vinci
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate safety of robot-assisted laparoscopic gastrectomy with lymph node dissection applied to gastric cancer of cStageIA/IB excluded from the indication of ESD.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Incidence of intraperitoneal inflectional complication (anastomotic leakage, pancreatic fistula and intraperitoneal abscess)
Key secondary outcomes	Incidence of accomplishment of robotic surgery, incidence of adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Histolically proved as gastric carcinoma by biopsy 2.cStageIA(T1N0) or cStageIB(T1N1, T2N0) diagnosed by imaging examinations 3.Excluded from the indication of ESD using gastroendoscopy 4.No invasion to the esophagus or duodenum. Radical resection is expected by distal gastrectomy or spleen-preserving total gastrectomy. Regardless of number of lesions. 5.PS(ECOG) 0 or 1 6.Full informed consent with candidates by the document
Key exclusion criteria	1.BMI exceeding 30 2.History of surgery in the upper abdomen, or surgery with intestinal resection 3. History of chemotherapy (including hormonal therarpy) or radiation also for other neoplasm lesions
Target sample size	20

Research contact person
Name of lead principal investigator	Takahiro Kinoshita
Organization	National Cancer Center Hospital East
Division name	Gastric Surgery Division
Address	6-5-1 Kashiwanoha, Kashiwa, 277-8577 Chiba
TEL	04-7133-1111
Email	takkinos@east.ncc.go.jp

Public contact
Name of contact person	Takahiro Kinoshita
Organization	National Cancer Center Hospital East
Division name	Gastric Surgery Division
Address	6-5-1 Kashiwanoha, Kashiwa, 277-8577 Chiba
TEL	04-7133-1111
Homepage URL
Email	takkinos@east.ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立がん研究センター東病院（千葉県）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 05 Month 14 Day
Anticipated trial start date	2014 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete	2016 Year 11 Month 13 Day
Date analysis concluded	2016 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 27 Day
Last modified on	2018 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018979