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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024040
Receipt No. 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 2018/07/30

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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
Middle name
Last name Yoshitaka Aoki
Organization Shizuoka General Hospital
Division name Department of Anesthesiology
Zip code
Address 4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
TEL 054-247-6111
Email ysyaoki27@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Aoki
Organization Shizuoka General Hospital
Division name Department of Anesthesiology
Zip code
Address 4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
TEL 054-247-6111
Homepage URL
Email ysyaoki27@gmail.com

Sponsor
Institute Shizuoka General Hospital
Institute
Department

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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2016 Year 05 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 21 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
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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