UMIN-CTR Clinical Trial

Public title

Short-term outcomes and potential advantages of robotic gastrectomy for gastric cancer in comparison with conventional laparoscopic approach.

Acronym

Robotic vs. laparoscopic gastrectomy for gastric cancer.

Scientific Title

Short-term outcomes and potential advantages of robotic gastrectomy for gastric cancer in comparison with conventional laparoscopic approach.

Scientific Title:Acronym

Robotic vs. laparoscopic gastrectomy for gastric cancer.

Region

Japan

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Operative medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine whether use of surgical robot reduces postoperative complications especially related to surgical maneuver.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Morbidity

Key secondary outcomes

Postoperative hospital stay

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Robotic gastrectomy

Interventions/Control_2

Laparoscopic gastrectomy

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Primary gastric cancer for which surgical treatment was applicable(cStageI-III)

Key exclusion criteria

Palliative operation: H(+), P(+), Cy(+)
Insufficient physical function (open gastrectomy, reduced extent of lymphadenectomy).
Double cancer.
Initial 10 cases for each operating surgeons.

Target sample size

650

Name of lead principal investigator

1st name	Ichiro
Middle name
Last name	Uyama

Organization

Fujita Health University

Division name

Division of Upper GI, Department of Surgery

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi

TEL

0562-93-9254

Email

iuyama@fujita-hu.ac.jp

Name of contact person

1st name	Koichi
Middle name
Last name	Suda

Organization

Fujita Health University

Division name

Division of Upper GI, Department of Surgery

Zip code

470-1192

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi

TEL

0562-93-9254

Homepage URL

Email

ko-suda@fujita-hu.ac.jp

Institute

Division of upper GI, Department of surgery, Fujita Health Univeristy

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Institutional Review Board of Fujita Health University

Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi

Tel

0562-93-2865

Email

f-irb@fujita-hu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

藤田医科大学（愛知県）

Date of disclosure of the study information

2013

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

526

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

Recruitment status

Main results already published

Date of protocol fixation

2008

Year

12

Month

01

Day

Date of IRB

2009

Year

01

Month

05

Day

Anticipated trial start date

2009

Year

01

Month

10

Day

Last follow-up date

2021

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Suda K, Man-I M, Ishida Y, Kawamura Y, Satoh S, Uyama I. Potential advantages of robotic radical gastrectomy for gastric adenocarcinoma in comparison with conventional laparoscopic approach: a single institutional retrospective comparative cohort study. Surg Endosc 2015;29:673-685.

Nakauchi M, Suda K, Shibasaki S, Kadoya S, Inaba K, Ishida Y, Uyama I. Comparison of the long-term outcomes of robotic radical gastrectomy for gastric cancer and conventional laparoscopic approach: a single institutional retrospective cohort study. Surg Endosc 2016;30:5444-5452.

Shibasaki S, Suda K, Nakauchi M, Nakamura K, Kikuchi K, Inaba K, Uyama I. Non-robotic minimally invasive gastrectomy as an independent risk factor for postoperative intra-abdominal infectious complications: A single-center, retrospective and propensity score-matched analysis. World J Gastroenterol 2020;26:1172-1184

Nakauchi M, Suda K, Shibasaki S, Kikuchi K, Kadoya S, Inaba K, Uyama I. Prognostic factors of minimally invasive surgery for gastric cancer: Does robotic gastrectomy bring oncological benefit? World J Gastroenterol 2021; 27:6659-6672.

Shibasaki S, Nakauchi M, Serizawa A, Nakamura K, Akimoto S, Tanaka T, Inaba K, Uyama I, Suda K. Clinical advantage of standardized robotic total gastrectomy for gastric cancer: A single-center retrospective cohort study using propensity-score matching analysis. Gastric Cancer 2022;25:804-816

Shibasaki S, Suda K, Hisamori S, Obama K, Terashima M, Uyama I. Robotic gastrectomy for gastric cancer: systematic review and future directions.Gastric Cancer 2023 May;26:325-338.

Registered date

2013

Year

09

Month

13

Day

Last modified on

2024

Year

03

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013738