UMIN-CTR Clinical Trial

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
Email	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
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	Shizuoka General Hospital
Address	4-27-1 Kita Ando Aoi-ku, Shizuoka City Japan
Tel	054-247-6111
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027684