UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024040 |
|---|---|
| Receipt number | R000027684 |
| Scientific Title | Evaluation of perioperative landiolol administration for preventing atrial fibrillation during esophagectomy. |
| Date of disclosure of the study information | 2016/09/13 |
| Last modified on | 2020/11/04 19:56:22 |
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Basic information
Public title
Evaluation of perioperative landiolol administration for preventing atrial fibrillation during esophagectomy.
Acronym
Perioperative landiolol for preventing atrial fibrillation during esophagectomy.
Scientific Title
Evaluation of perioperative landiolol administration for preventing atrial fibrillation during esophagectomy.
Scientific Title:Acronym
Perioperative landiolol for preventing atrial fibrillation during esophagectomy.
Region
| Japan |
Condition
Condition
Esophageal cancer(Esophagectomy)
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether perioperative atrial fibrillation incidence reduced or not during esophagectomy by landiolol administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Perioperative atrial fibrillation incidence (within 96 hours)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Landiolol administration
Interventions/Control_2
Placebo administration
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) surgery patients with histologically or cytologically confirmed esophageal cancer
(2) patient age is below 20 years of age or older and 80 years of age at the time of obtaining informed consent
(3) sufficient understanding of participation in the study, patients with written consent by the free will of the person has been obtained
(4) surgery expression arthroscopic esophagus resection, the patient's stomach tube reconstruction
Key exclusion criteria
(1) history of arrhythmias (atrial fibrillation, atrioventricular block, etc.)
(2) bradycardia from the preoperative period (heart rate 50 / min or less)
(3) thyroid dysfunction (hyperthyroidism, hypothyroidism)
(4) B blocker use from the preoperative period
(5) history of asthma
(6) heart failure hospitalizations, low cardiac function in the preoperative echocardiography (left ventricular ejection fraction less than 30%)
(7) untreated pheochromocytoma
Target sample size
188
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Aoki |
Organization
Shizuoka General Hospital
Division name
Department of Anesthesiology
Zip code
4208527
Address
4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
TEL
054-247-6111
ysyaoki27@gmail.com
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Aoki |
Organization
Shizuoka General Hospital
Division name
Department of Anesthesiology
Zip code
4208527
Address
4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
TEL
054-247-6111
Homepage URL
ysyaoki27@gmail.com
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka General Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka General Hospital
Address
4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
Tel
054-247-6111
akiko-mochizuki@shizuoka-pho.jp
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
静岡県立総合病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 13 | 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
| 2016 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 13 | Day |
Last modified on
| 2020 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027684
