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
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
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
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
