UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036674 |
|---|---|
| Receipt number | R000041789 |
| Scientific Title | Observational study of feasibility of efficacy and safety of new endoscopic treatment for early gastric cancers |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2019/05/08 10:54:57 |
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Basic information
Public title
Observational study of feasibility of efficacy and safety of new endoscopic treatment for early gastric cancers
Acronym
Observational study of feasibility of efficacy and safety of new endoscopic treatment for early gastric cancers
Scientific Title
Observational study of feasibility of efficacy and safety of new endoscopic treatment for early gastric cancers
Scientific Title:Acronym
Observational study of feasibility of efficacy and safety of new endoscopic treatment for early gastric cancers
Region
| Japan |
Condition
Condition
Early gastric cancers
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety in endoscopic submucosal tunnel dissection for early gastric cancers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative complication rates in endoscopic submucosal tunnel dissection
Key secondary outcomes
Surgical process (operative time, devices, general anesthesia operation transfer rate), postoperative course (oral intake, length of stay, inflammatory findings, the rates of late complications, stenosis), postoperative overall survival rate
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Early gastric cancers (T1a)
2. Performance status 0 and 2
3. Plt => 100,000/mm3
Creatinine <= 3.0 mg/dl
AST <= 200 IU/L
ALT <= 200 IU/L
T-bil <= 2.0 mg/dl
Hb => 8.0 g/dl
4. Patients who gave written informed consent before entry in this study
Key exclusion criteria
1. Ischemic heart disease
2. Liver cirrhosis, active hepatitis
3. Interstitial pneumonia
4. Haemodialysis
5. Both malignant disorder
6. Doctor's decision not to register to this regimen
Target sample size
1033
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
641-8510
Address
811-1 Kimiidera, Wakayama
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
641-8510
Address
811-1 Kimiidera, Wakayama
TEL
073-441-0613
Homepage URL
tojima@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University School of Medicine,Second Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University School of Medicine,Second Department of Surgery
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
Wakayama Medical University Hospital
Address
811-1 Kimiidera, Wakayama
Tel
073-441-0613
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 外科学第2講座
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 08 | 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 | 05 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collect data.
Management information
Registered date
| 2019 | Year | 05 | Month | 08 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041789
