UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028372 |
|---|---|
| Receipt number | R000032226 |
| Scientific Title | Safety and feasibility of laparoscopic gastrectomy for resectable advanced gastric cancer |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2019/07/27 12:01:46 |
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Basic information
Public title
Safety and feasibility of laparoscopic gastrectomy for resectable advanced gastric cancer
Acronym
Safety and feasibility of laparoscopic gastrectomy for resectable advanced gastric cancer
Scientific Title
Safety and feasibility of laparoscopic gastrectomy for resectable advanced gastric cancer
Scientific Title:Acronym
Safety and feasibility of laparoscopic gastrectomy for resectable advanced gastric cancer
Region
| Japan |
Condition
Condition
Advanced gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and feasibility of laparoscopic gastrectomy for resectable advanced gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of surgical complications greater than Grade III (Clavien-Dindo classification)
Key secondary outcomes
Proportion of conversion to open surgery, Incidence of adverse events, overall survival, recurrence-free survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic gastrectomy
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed gastric adenocarcionoma
2) cStage I, II or III disease curably treated with total, proximal, or distal gastrectomy with lymph node dissection
3) Eastern Cooperative Oncology Group (ECOG) PS of 0-1
4) Age over 18
5) Informed consent is obtained
Key exclusion criteria
1) Patients with psychiatric or mental disorders
2) Possibly pregnant, or breast feeding woman
3) Paticents with acute myocardial infaction in 6 months or with unstable ungina
4) Patients with pulmonary disease and require continuous oxygen therapy
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Hiroya |
| Middle name | |
| Last name | Takeuchi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Surgery
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL
053-435-2279
takeuchi@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hiramatsu |
Organization
Hamamatsu University School of Medicine
Division name
Department of Surgery
Zip code
4313192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL
053-435-2279
Homepage URL
hiramatu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu 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
Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
Tel
053-435-2680
rinri@hama-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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | 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
| 2017 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 25 | Day |
Last modified on
| 2019 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032226
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
