UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004394 |
|---|---|
| Receipt number | R000005253 |
| Scientific Title | Prospective study of efficacy of prophylactic hemostasis for ulceration post endoscopic submucosal dissection of early gastric tumor. |
| Date of disclosure of the study information | 2010/10/16 |
| Last modified on | 2010/10/16 15:50:18 |
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Basic information
Public title
Prospective study of efficacy of prophylactic hemostasis for ulceration post endoscopic submucosal dissection of early gastric tumor.
Acronym
Efficacy of hemostasis post ESD.
Scientific Title
Prospective study of efficacy of prophylactic hemostasis for ulceration post endoscopic submucosal dissection of early gastric tumor.
Scientific Title:Acronym
Efficacy of hemostasis post ESD.
Region
| Japan |
Condition
Condition
Early gastric cancer and adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is this study is to evaluate the efficacy of prophylactic hemostasis post endoscopic submucosal dissection for early gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retio of delayed bleeding(hematemesis or melena required endoscopic hemostasis, decreased the hemoglobin count by more than 2g/dl)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic submucosal dissection
Interventions/Control_2
coagulation
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
Patients who were diagnosed as early gastric cancer or gastric adenoma and are considered as the indication of endoscopic submucosal dissection.
Patients who understand the study contents and give informed consents by themselves
Key exclusion criteria
1.Patient with major organ failure(heart failure,renal failure,liver failure, Respiratory failure)
2, Patients who have anticoagulant or antiplatelet therapy and who cannot stop it.
3.Patient with Pacer planting
4. Patients who were judged inappropriate by their physicians.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Machida Hirohisa |
Organization
Osaka City University Graduate School of Medicine, Osaka, Japan
Division name
Department of Gastroenterology
Zip code
Address
Asahimachi abenoku oosaka citu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka City University Graduate School of Medicine, Osaka, Japan
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
School of Medicine, Osaka, Japan
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Osaka, Japan
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 10 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 16 | Day |
Last modified on
| 2010 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005253
