UMIN-CTR Clinical Trial

Basic information
Public title	Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer.
Acronym	Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer.
Scientific Title	Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer.
Scientific Title:Acronym	Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer.
Region	Japan

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

Objectives
Narrative objectives1	To clarify the safety and validity of robot (Da Vinci Xi) assisted gastrectomy for early gastric cancer with fluorescence navigation by gastric submucosal injection of ICG.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative complication rate of Grade 2 or higher according to Clavien-Dindo classification.
Key secondary outcomes	Completion rate of robot assisted gastrectomy, operation time, volume of blood loss, intraoperative complication rate of Grade 3 or higher according to CTCAE classification, Postoperative complication rate of Grade 3 or higher according to Clavien-Dindo classification, postoperative course evaluated by Inflammatory findings (WBC, CRP), body temperature, drain amylase value, number of days to post-operative flatus, postoperative hospital days), presence or absence of malignant tumor on dissected resected surface in pathological examination, number of excised lymph nodes.

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 gastrectomy using fluorescence navigation by gastric submucosal injection of ICG.
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)Patients diagnosed as clinical stage I and cT1 gastric cancer by preoperative examination. (2)PS (ECOG) is 0 or 1. (3)Body mass index (BMI) is less than 30. (4)Patients without poorly controlled complications. (5)No history of chemotherapy (including endocrine therapy) and/or radiotherapy for any carcinomas. (6)It satisfies all the conditions below. (The latest examination value within 60 days before registration is used for all examination items.) a)WBC >= 3,000 / mm 3 b)Plt >= 100,000 / mm 3 c)AST <= 100 IU / L, ALT <= 100 IU / L d)T.Bil <= 2.0 g / dl e)Serum creatinine <= 1.5 mg / dl (7)The patient himself / herself signed the consent form approved by the ethics committee.
Key exclusion criteria	(1) Patients with active multiple primary cancers (simultaneous or metachronous with disease-free period within 5 years). (2) Patients who have a history of frequent laparotomy and are expected to have severe intraperitoneal adhesions. (3) Patients with a history of ICG hypersensitivity. (4) Patients with severe complications (liver disease, renal disease, heart disease, blood disease, metabolic disease). (5) Possible pregnancy or lactating female patients. (6) Patients undergoing continuous systemic administration (ingestion or intravenous) of corticosteroids. (7) Patients who are complicated of psychosis or psychiatric symptoms and judged to be difficult to participate in the exam. (8) Patients judged inappropriate for participation in this study by the research director.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazuhiro Imamura
Organization	Tokyo Meropolitan Tama Medical Center
Division name	Department of Surgery
Zip code
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL	042-323-5111
Email	imamurakazu@mac.com

Public contact
1st name of contact person	1st name Middle name Last name Kazuhiro Imamura
Organization	Tokyo Meropolitan Tama Medical Center
Division name	Department of Surgery
Zip code
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL	042-323-5111
Homepage URL
Email	imamurakazu@mac.com

Sponsor
Institute	Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Tama Medical Center
Organization
Division
Category of Funding Organization	Local Government
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	東京都立多摩総合医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 04 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
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 02 Month 28 Day
Date of IRB	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2020 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 25 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036195