UMIN-CTR Clinical Trial

Basic information
Public title	Robotic gastrectomy versus laparoscopic gastrectomy in patients with gastric cancer: A randomized Phase III trial
Acronym	Robotic gastrectomy vs. laparoscopic gastrectomy
Scientific Title	Robotic gastrectomy versus laparoscopic gastrectomy in patients with gastric cancer: A randomized Phase III trial
Scientific Title:Acronym	Robotic gastrectomy vs. laparoscopic gastrectomy
Region	Japan

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

Objectives
Narrative objectives1	We compare the robotic gastrectomy with the conventional laparoscopic gastrectomy for patients with resectable gastric cancer in terms of surgical safety and oncological feasibility.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Incidence of intra-abdominal infectious complications (pancreatic fistula, intra-abdominal abscess, and anastomotic leakage) with more than Clavien-Dindo grade 2
Key secondary outcomes	Incidence of postoperative complications, duration of surgery, blood loss, blood transfusion, time to first oral intake, length of stay, relapse-free survival, overall survival rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	A: Laparoscopic gastrectomy with lymph node dissection
Interventions/Control_2	B: Robotic gastrectomy with lymph node dissection
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven gastric carcinoma 2) Resectable gastric cancer 3) Not applicable of ESD according to the Japanese classification 4) Excluding esophageal invasion (thoracic esophagus) or duodenal invasion (second portion) 5) Aged 20 to 90 year 6) PS (ECOG) 0 or 1 7) BMI < 35 8) No history of gastrointestinal surgery 9) No history of chemotherapy or radiotherapy 10) Normal function of the major organs; indicated by a leukocyte count of over 3000 mm3, a platelet count of over 100 000 mm3, aspartate aminotransferase and alanine aminotransferase levels less than 200 IU/L, total bilirubin less than 3 g/dl and creatinine levels less than 2 mg/dl. 11) Proven written informed consent
Key exclusion criteria	1) Synchronous or metachronous malignancies other than carcinoma in situ 2) Pregnancy or breast-feeding 3) Severe mental disease 4) Continuous systemic steroid therapy 5) History of myocardial infarction or unstable angina pectoris within six months 6) Uncontrollable hypertension 7) Uncontrollable diabetes mellitus or administration of insulin 8) Respiratory disease requiring continuous oxygen therapy 9) History of deep vein thrombosis 10)Doctors decision not to register to this trial
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Toshiyasu Middle name Last name Ojima
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Zip code	6418510
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Email	tojima@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Toshiyasu Middle name Last name Ojima
Organization	Wakayama Medical University, School of Medicine
Division name	Second Department of Surgery
Zip code	6418510
Address	811-1, Kimiidera, Wakayama 641-8510, Japan
TEL	073-441-0613
Homepage URL
Email	tojima@wakayama-med.ac.jp

Sponsor
Institute	Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization	Second Department of Surgery, Wakayama Medical University, School of Medicine
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	Second Department of Surgery, Wakayama Medical University
Address	Kimiidera 811-1, Wakayama
Tel	0734410613
Email	tojima@wakayama-med.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	和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	240
Results	JAMA Surg. 2021 Oct 1;156(10):954-963. doi: 10.1001/jamasurg.2021.3182.
Results date posted	2022 Year 09 Month 03 Day
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	Completed
Date of protocol fixation	2018 Year 03 Month 01 Day
Date of IRB	2018 Year 03 Month 31 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	JAMA Surg. 2021 Oct 1;156(10):954-963. doi: 10.1001/jamasurg.2021.3182.

Management information
Registered date	2018 Year 03 Month 01 Day
Last modified on	2022 Year 09 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036007