UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007170 |
|---|---|
| Receipt number | R000008345 |
| Scientific Title | Multicenter Randomized Controlled Trial to Assess the Necessity of Second-look Endoscopy after Endoscopic Submucosal Dissection (ESD) for gastric neoplasms: the SAFE study |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2013/05/05 08:29:44 |
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Basic information
Public title
Multicenter Randomized Controlled Trial to Assess the Necessity of Second-look Endoscopy after Endoscopic Submucosal Dissection (ESD) for gastric neoplasms: the SAFE study
Acronym
SAFE study
Scientific Title
Multicenter Randomized Controlled Trial to Assess the Necessity of Second-look Endoscopy after Endoscopic Submucosal Dissection (ESD) for gastric neoplasms: the SAFE study
Scientific Title:Acronym
SAFE study
Region
| Japan |
Condition
Condition
early gastric cancer/gastric adenoma
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the necessity of a second-look endoscopy after gastric endoscopic submucosal dissection(ESD).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
post-ESD bleeding rate (soon after ESD to 28 days after ESD)
Key secondary outcomes
1)late post-ESD bleeding rate (from 2 days after ESD to 28 days after ESD)
2)post-ESD bleeding rate classified by tumor location, tumor size and ulcerative findings
3)blood transfusion rate after ESD
4)risk factor for post-ESD bleeding
5)coagulation procedure rate during the second-look endoscopy
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
second-look endoscopy will be performed after gastric ESD
Interventions/Control_2
second-look endoscopy will not be performed after gastric ESD
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) Clinical diagnosis of Stage IA gastric cancer or gastric adenoma, and highly suspicion of Stage IA gastric cancer.
2) With only one lesion which will be treated endoscopically.
3) Aged 20 years old or over.
4) PS (ECOG) of 0 to 2.
5) Meet all of the following criteria without blood transfusion in the past 14 days.
i) Hb: >=9g/dl
ii) Plt: >=100000/mm3
iii) AST, ALT: <=100
iv) Cre: <=2.0mg/dl
v) PT%: >=80%
vi) APTT: <=40sec
6) Available to be observed more than 28 days after ESD.
7) With written informed consent.
Key exclusion criteria
1) History of gastrectomy or reconstruction of gastric tube.
2) History of radiation therapy to the upper abdominal region.
3) With a scheduled endoscopic treatment for esophageal lesion or duodenal lesion concurrently.
4) History of endoscopic treatment for upper GI lesion in the past 28 days.
5) With a scheduled endoscopic treatment for upper GI lesion in 28 days after gastric ESD.
6) With an allergy to proton pomp inhibitor.
7) Systemic administration (intravenously or orally) of either one or more drugs of corticosteroid, anticoagulant agent or antiplatelet agent.
8) Systemic administration of non-steroid anti-inflammatory drug which cannot be suspended through 7 days before to 28 days after gastric ESD.
9) Pregnant or lactation woman.
10) Diagnosis of psychosis.
11) With active bacterial or fungus infection.
12) History of myocardial infarction or unstable angina pectoris within 3 months.
13) With uncontrollable hypertension.
14) With severe respiratory disease requiring continuous oxygen therapy.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Fujishiro |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Endoscopy and Endoscopic Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Department of Endoscopy and Endoscopic Surgery
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, University of Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital East, Osaka Medical Center for Cancer and Cardiovascular Diseases, Cancer Institute Hospital, National Cancer Center Hospital
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
東京大学医学部附属病院(東京都)、国立がん研究センター東病院(千葉県)、大阪府立成人病センター(大阪府)、がん研有明病院(東京都)、国立がん研究センター中央病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 30 | Day |
Last modified on
| 2013 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008345
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