UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002745 |
|---|---|
| Receipt number | R000002697 |
| Scientific Title | Endoscopic Doppler ultrasound for prevention of delayed bleeding from ulcer after endoscopic submucosal dissection for early gastric cancer |
| Date of disclosure of the study information | 2009/11/12 |
| Last modified on | 2012/05/11 09:05:57 |
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Basic information
Public title
Endoscopic Doppler ultrasound for prevention of delayed bleeding from ulcer after endoscopic submucosal dissection for early gastric cancer
Acronym
DopUS_post ESD study
Scientific Title
Endoscopic Doppler ultrasound for prevention of delayed bleeding from ulcer after endoscopic submucosal dissection for early gastric cancer
Scientific Title:Acronym
DopUS_post ESD study
Region
| Japan |
Condition
Condition
Bleeding from ulcer after endoscopic submucosal dissection for early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate usefulness of endoscopic Doppler ultrasound on reduction of bleeding from post ESD ulcer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Rate of delayed hemorrhage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Assessment of blood flow signal in post ESD ulcer by Doppler ultrasound probe system
Interventions/Control_2
No intervention
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) Patients underwent endoscopic submucosal dissection for mucosal early gastric cancers that was larger than 2 cm without ulcer or scar or less than 3 cm with scar
2) Written informed consent
Key exclusion criteria
Post gastrectomy
Major organ failure
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriya Uedo |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Gastrointestinal Oncology
Zip code
Address
1-3-3, Nakamichi, Higashinari-ku, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoko Nishizawa |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Clinical research center
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka foundation for the prevention of cancer and cardiovascular diseases
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 12 | 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
| 2008 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 12 | Month | 01 | Day |
Other
Other related information
Candidates will be consecutively enrolled.
After applying Doppler US and endoscopic coagulation, outcomes will be prospectively investigated.
Outcomes will be compared with that of sex-, age-, tumor size-, and presence of ulcer- matched historical cohort.
Management information
Registered date
| 2009 | Year | 11 | Month | 11 | Day |
Last modified on
| 2012 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002697
