UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003647 |
|---|---|
| Receipt number | R000004414 |
| Scientific Title | Endoscopic submucosal dissection for early gastric cancer: A prospective study |
| Date of disclosure of the study information | 2010/05/21 |
| Last modified on | 2015/06/08 16:32:24 |
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Basic information
Public title
Endoscopic submucosal dissection for early gastric cancer: A prospective study
Acronym
Endoscopic submucosal dissection for early gastric cancer: A prospective study
Scientific Title
Endoscopic submucosal dissection for early gastric cancer: A prospective study
Scientific Title:Acronym
Endoscopic submucosal dissection for early gastric cancer: A prospective study
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To invastigate the long-term survival, efficacy, and safety of endoscopic submucosal dissection for early gastric cancers ,which was indicated in guidline of Japanese Gastric Cancer Association.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
5year overall survival rate (OS)
Key secondary outcomes
1) OS at UL(-) group
2) OS at UL(+) group
3) Disease free survival rate
4) the rate of avoidance from gastrectomy
5) enbloc resection rate
6) Curative resection rate
7) side effect
8) serious side effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
endoscopic submucosal dissection (ESD)
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) a biopsy-proven, differentiated adenocarcinoma, exclude undifferentiated adenocarcinoma.
2)initial and single lesion.
3)tumor depth confined to the mucosa.
4)endoscopically findings
a) UL(-)group, any size
b) UL(+)group, <=30mm
5) possible to enbloc resection
6) less possibility of stricture
7) no findings of any LN swelling, any metastasis on CT(N0,M0).
8) PS is 0 or 1.
9) no synchronus and/or metachronus carcinoma of stomach.
10) no histoly of any cancer.
11)
a) WBC>=3,000/mm3 and <=12,000/mm3
b) Hb>=9.0g/dL
c) Plt>=100,000/mm3
d) AST, ALT<=100 IU/L
e) T-bil <=2.0mg/dL
f) Cr<=2.0mg/dL
12)Voluntary signed and dated written informed consent from all the patients was obtained.
Key exclusion criteria
1)continuous medication of anti- coagulate drugs
2)double cancer
3)Pregnant or lactating Women
4)Psychological conditions that may interfere with the patient's compliance and evaluation of the study results
5)Patients with continuous medication of steroid.
6) Patients with active clinically serious infection.
7) Active coronary artery disease less than 3 months prior to study entry
8)Patients with uncontrolled HT.
9)Patients with uncontrolled DM.
10)Patients with respiratory disease with HOT.
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kingo Hirasawa |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
kingo-h@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kingo Hirasawa |
Organization
Yokohama City University Medical Center
Division name
Gastroenterological Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
kingo-h@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical CenterGastroenterological Center
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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 21 | 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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | 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
| 2010 | Year | 05 | Month | 21 | Day |
Last modified on
| 2015 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004414
