UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031536
Receipt number R000036007
Scientific Title Robotic gastrectomy versus laparoscopic gastrectomy in patients with gastric cancer: A randomized Phase III trial
Date of disclosure of the study information 2018/03/01
Last modified on 2022/09/03 12:12:16

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036007


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name