UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052213 |
|---|---|
| Receipt number | R000059584 |
| Scientific Title | Prospective cohort study on the safety and effectiveness of robot-assisted laparoscopic gastrectomy and laparoscopic gastrectomy in gastric cancer patients. |
| Date of disclosure of the study information | 2023/09/16 |
| Last modified on | 2023/09/14 19:32:00 |
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Basic information
Public title
Prospective cohort study on the safety and effectiveness of robot-assisted laparoscopic gastrectomy and laparoscopic gastrectomy in gastric cancer patients.
Acronym
Prospective cohort study on the safety and effectiveness of RAG and LAG in gastric cancer patients.
Scientific Title
Prospective cohort study on the safety and effectiveness of robot-assisted laparoscopic gastrectomy and laparoscopic gastrectomy in gastric cancer patients.
Scientific Title:Acronym
Prospective cohort study on the safety and effectiveness of RAG and LAG in gastric cancer patients.
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness and safety of laparoscopic and robot-assisted gastrectomy for gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total complication rate
Key secondary outcomes
Completion rate of the robotassisted laparoscopic or laparoscopic gastrectmy, operative time, blood loss, number of lymph nodes dissected, length of postoperative hospital stay, postoperative pain evaluated by VAS, medical costs, relase free survival , overall survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Gastric cancer was diagnosed by histological examination of an endoscopic biopsy specimen.
2) The lesion does not meet the indication of endoscopic resection but surgical resection.
3) The tumor has been diagnosed as potentially resectable by comprehensive diagnosis using endoscopy and preoperative imaging (endoscopy or abdominal/pelvic CT).
4) The age of subjects are over 20 years old.
5) ECOG-PS is 0, 1, or 2.
6) All of the following conditions are met. (All test items are used the latest test values taken within 56 days before registration. Testing on the same day of the week 8 weeks before the registration date is acceptable.)
1. White blood cell count >=3,000/mm3
2. Platelet count >=100,000/mm3
3. AST<=100IU/L, ALT<=100IU/L
4. Total bilirubin <=2.0 g/dl
5. Serum creatinine <=1.5mg/dl
6. Written consent has been obtained from the subject
to participate in the study.
Key exclusion criteria
1) Subjects with distant metastasis to other organs or peritoneal dissemination
2) Subjects who have previously undergone intra-abdominal surgery for other diseases and are expected to have severe adhesions.
3) The subjects have active multiple cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free period of 5 years or less). However, the lesions equivalent to carcinoma in situ (carcinoma in situ) or intramucosal cancer that can be cured by local treatment are not included in active double cancer.
4) Women who may be pregnant or are breastfeeding.
5) Subjects with mental illness or psychiatric symptoms .
6) Subjects receiving continuous systemic administration of steroids (orally or intravenously).
7) History of myocardial infarction within 6 months or unstable angina.
8) Concomitant with poorly controlled hypertension.
9) Currently being treated with insulin or having uncontrolled diabetes.
10) Subjects have a respiratory disease that requires continuous oxygen administration.
11) Other patients deemed unsuitable as subjects by the research director
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Omori |
Organization
Osaka International Cancer Institute
Division name
Division of gastroenterological surgery
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Osaka, Japan
TEL
0669451181
takeshi.oomori@oici.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Shinno |
Organization
Osaka International Cancer Institute
Division name
Division of gastroenterological surgery
Zip code
5418567
Address
3-1-69, Otemae, Chuo-ku, Osaka, Osaka, Japan
TEL
0669451181
Homepage URL
naoki.shinno@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Osaka International Cancer Institute
Address
3-1-69, Otemae, Chuo-ku, Osaka, Osaka, Japan
Tel
0669451181
rinri01@opho.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pre-registration examination and evaluation items
1) Patient background
2) Target disease information
3) Clinical examination (within 14 days before registration)
4) Imaging tests (within 4 weeks before registration) Imaging tests such as CT and MRI
Surgery and surgical findings
Postoperative findings
Post-discharge evaluation items
Patients will visit the hospital every 6 months for up to 5 years after registration and undergo the following tests.
1) Clinical examination
2) Chest, abdomen, and pelvis contrast-enhanced CT or abdominal ultrasound were performed alternately.
3) Postoperative late complications (JCOG intraoperative and postoperative complications criteria/CTCAEv4.0) (adverse reactions)
Management information
Registered date
| 2023 | Year | 09 | Month | 14 | Day |
Last modified on
| 2023 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059584
