UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008214 |
|---|---|
| Receipt number | R000009651 |
| Scientific Title | Effect of Surgicel (Fibrillar) on prevention for delayed bleeding after endoscopic submucosal dissection for gastric epithelial tumors |
| Date of disclosure of the study information | 2012/06/19 |
| Last modified on | 2015/07/22 19:05:12 |
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Basic information
Public title
Effect of Surgicel (Fibrillar) on prevention for delayed bleeding after endoscopic submucosal dissection for gastric epithelial tumors
Acronym
Effect of Surgicel (Fibrillar) on prevention for delayed bleeding after ESD
Scientific Title
Effect of Surgicel (Fibrillar) on prevention for delayed bleeding after endoscopic submucosal dissection for gastric epithelial tumors
Scientific Title:Acronym
Effect of Surgicel (Fibrillar) on prevention for delayed bleeding after ESD
Region
| Asia(except Japan) |
Condition
Condition
Patients who underwent ESD for gastric epithelial tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
comparsion of effect on prevention for ulcer bleeding after ESD between combination therapy with surgicel and H2RA and monotherapy with PPI
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bleeding rates during follow up period after ESD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Combination theratpy with Surgicel and H2RA
Interventions/Control_2
Monotherapy with PPI
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
Patients who will undergo ESD for gastric epithelial tumors
Key exclusion criteria
Patients who have disease with bleeding tendency
Target sample size
157
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Su Jin Hong |
Organization
Soonchunhyang University College of Medicine
Division name
Digestive Disease Center, Department of Internal Medicine
Zip code
Address
Digestive Disease Center, Soonchunhyang University Bucheon Hospital,
TEL
82-32-621-5087
drhsj@schmc.ac.kr
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Su Jin Hong |
Organization
Soonchunhyang University College of Medicine
Division name
Digestive Disease Center, Department of Internal Medicine
Zip code
Address
Digestive Disease Center, Soonchunhyang University Bucheon Hospital,
TEL
82-32-621-5087
Homepage URL
sjhong@schmc.ac.kr
Sponsor or person
Institute
Soonchunhyang University College of Medicine
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Non profit foundation
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
Soonchunhyang University, Bucheon Hospital
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 19 | 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
| 2012 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | Day |
Last modified on
| 2015 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009651
