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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007170
Receipt No. 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

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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
Last 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
Email

Public contact
1st 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
Email

Sponsor
Institute Graduate School of Medicine, University of Tokyo
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008345

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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