UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001868 |
|---|---|
| Receipt number | R000002248 |
| Scientific Title | Partial gastrectomy with combined endoscopic and laparoscopic approach for early gastric cancer |
| Date of disclosure of the study information | 2009/04/10 |
| Last modified on | 2015/04/02 09:10:10 |
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Basic information
Public title
Partial gastrectomy with combined endoscopic and laparoscopic approach for early gastric cancer
Acronym
Partial gastrectomy with combined endoscopic and laparoscopic approach
Scientific Title
Partial gastrectomy with combined endoscopic and laparoscopic approach for early gastric cancer
Scientific Title:Acronym
Partial gastrectomy with combined endoscopic and laparoscopic approach
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the curability and less invasiveness of full thickness resection with combined endoscopic and laparoscopic approach for early gastric cancer which is not indicated for endoscopic submucosal dissection (ESD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Relapse-free survival
Key secondary outcomes
Success rate, intra and post-operative morbidity, and overall survival rate
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
Full thickness resection and limited lymphadenectomy with combined endoscopic and laparoscopic approach for early gastric cancer.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Early gastric cancer patient
Informed consent
Key exclusion criteria
lymph node metastasis
distant metastasis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiro Inoue, MD, PhD |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL
03-6204-6000
haruinoue777@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiro Inoue, MD, PhD |
Organization
Showa University Koto Toyosu Hospital
Division name
Digestive Disease Center
Zip code
Address
5-1-38 Toyosu, Koto-ku, Tokyo 135-8577, Japan
TEL
03-6204-6000
Homepage URL
haruinoue777@yahoo.co.jp
Sponsor or person
Institute
Digestive Disease Center, Showa University Koto Toyosu Hospital
Institute
Department
Personal name
Funding Source
Organization
Digestive Disease Center, Showa University Koto Toyosu Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
| 2009 | Year | 04 | Month | 10 | 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
| 2008 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 10 | Day |
Last modified on
| 2015 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002248
| 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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