UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012908 |
|---|---|
| Receipt number | R000012356 |
| Scientific Title | A study on the frequency of bacteremia due to endoscopic submucosal dissection for esophageal neoplasm. |
| Date of disclosure of the study information | 2014/01/21 |
| Last modified on | 2014/12/30 23:02:22 |
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Basic information
Public title
A study on the frequency of bacteremia due to endoscopic submucosal dissection for esophageal neoplasm.
Acronym
Bacteremia after Esophageal Endoscopic Resection Study (BEER Study)
Scientific Title
A study on the frequency of bacteremia due to endoscopic submucosal dissection for esophageal neoplasm.
Scientific Title:Acronym
Bacteremia after Esophageal Endoscopic Resection Study (BEER Study)
Region
| Japan |
Condition
Condition
esophaeal neoplasm
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the frequency of bacteremia due to esophageal ESD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of bacteremia after esophageal ESD
Key secondary outcomes
Relevance of bacteremia and fever of the esophagus after ESD
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Bacteremia will evaluate with repeat blood cultures, immediately after esophageal ESD, next morning and when showed a fever of 38 degrees or more.
Interventions/Control_2
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. Esophageal ESD patient.
2. 20 years old or older.
Key exclusion criteria
1. Patients using antibiotics within 7 days preoperative esophageal ESD.
2. Patients with fever and, the active infection systemic.
3. Patients attending physician has determined ineligible.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Ono |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
Address
1007 Shimonagakubo Nagaizumi-cho Sunto-gun, Shizuoka, 411-8777
TEL
055-989-5222
n.kawata@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noboru Kawata |
Organization
Shizuoka Cancer Center
Division name
Division of Endoscopy
Zip code
Address
749-1 Nakatogari Nagaizumi-cho Sunto-gun, Shizuoka, 411-0942
TEL
055-989-5222
Homepage URL
noboru.net.japan@gmail.com
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Cancer Center
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
静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 21 | 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
| 2013 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 21 | Day |
Last modified on
| 2014 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012356
