UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027649 |
|---|---|
| Receipt number | R000031679 |
| Scientific Title | A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2018/09/04 09:44:55 |
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Basic information
Public title
A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer
Acronym
A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer
Scientific Title
A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer
Scientific Title:Acronym
A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer
Region
| Japan |
Condition
Condition
Gastric cander
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the safety and the curability of laparoscopic total gastrectomy for cStage II or III advanced gastric cancer compared with those open total gastrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
anastomotic leakage, pancreatic fistula and intra-abdominal abscess
Key secondary outcomes
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 total 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Histologically proven gastric adenocarcinoma.
2) Diagnosed cStage II or III by endoscopy and CT.
3) Tumor located in the upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy.
4) Age: 20-90.
5) ECOG performance status 0-1.
6) Sufficient organ functions.
7) Written informed consent obtained from patients.
Key exclusion criteria
1) Pregnant or lactating female.
2) Patients with psychiatric disease or severe mental symptoms.
3) Patients with uncontrollable hypertension.
4) Patients with uncontrollable diabetes.
5) Other patients evaluated to be inadequate to participate in this study by investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Kojima |
Organization
Tokyo Medical and Dental University
Division name
Center for minimally Invasive surgery
Zip code
Address
1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL
+81-3-5803-5260
k-kojima.srg2@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiro Tanioka |
Organization
Tokyo Medical and Dental University Hospital
Division name
Department of Gastric Surgery
Zip code
Address
1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL
+81-3-5803-5260
Homepage URL
tanioka.srg1@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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 | 07 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031679
