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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010648
Receipt No. R000012452
Scientific Title Landiolol hydrochloride for prevention of postoperative atrial fibrillation after esophageal cancer surgery: The double-blind, randomized, placebo-controlled trial
Date of disclosure of the study information 2013/05/04
Last modified on 2016/02/18

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Basic information
Public title Landiolol hydrochloride for prevention of postoperative atrial fibrillation after esophageal cancer surgery: The double-blind, randomized, placebo-controlled trial
Acronym APPLE trial Phase III
(A Prophylactic study using Placebo or Landiolol after Esophagectomy)
Scientific Title Landiolol hydrochloride for prevention of postoperative atrial fibrillation after esophageal cancer surgery: The double-blind, randomized, placebo-controlled trial
Scientific Title:Acronym APPLE trial Phase III
(A Prophylactic study using Placebo or Landiolol after Esophagectomy)
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We compare to the prophylactic use of landiolol hydrochloride, an ultrashort-acting beta-blocker, after esophagectomy for the esophageal cancer patients in terms of decrease the incidence of postoperative atrial fibrillation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Incidence of postoperative atrial fibrillation
Key secondary outcomes Incidence of postoperative complications
Blood pressure, heart rate
Inflammatory index: WBC, CRP, IL-6, HMGB-1

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 NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intravenous placebo Glucose 5% after operation.
Interventions/Control_2 Intravenous landiolol hydrochloride after operation, 3 gamma, 72 hr.
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
85 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients undergoing a right transthoracic esophagectomy for esophageal cancer resection
2)No severe disturbance of liver function and renal function
3)Writen informed consent
Key exclusion criteria 1)Past of arrhythmia
2)Second -or third-degree AV block
3)Sinus bradycardia at rest < 50/min
4)With pacemaker
5)Clinical heart failure
6)Doctor's decision not to register to this regimen
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyasu Ojima
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama 641-8510, Japan
TEL 073-441-0613
Email tojima@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiyasu Ojima
Organization Wakayama Medical University
Division name Second Department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama 641-8510, Japan
TEL 073-441-0613
Homepage URL
Email tojima@wakayama-med.ac.jp

Sponsor
Institute Second Department of Surgery, Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization Second Department of Surgery, Wakayama Medical University, School of Medicine
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 04 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 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2016 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 04 Day
Last modified on
2016 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012452

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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