Unique ID issued by UMIN | UMIN000010648 |
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Receipt number | 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 20:01:52 |
Landiolol hydrochloride for prevention of postoperative atrial fibrillation after esophageal cancer surgery: The double-blind, randomized, placebo-controlled trial
APPLE trial Phase III
(A Prophylactic study using Placebo or Landiolol after Esophagectomy)
Landiolol hydrochloride for prevention of postoperative atrial fibrillation after esophageal cancer surgery: The double-blind, randomized, placebo-controlled trial
APPLE trial Phase III
(A Prophylactic study using Placebo or Landiolol after Esophagectomy)
Japan |
Esophageal cancer
Surgery in general | Gastrointestinal surgery |
Malignancy
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
Incidence of postoperative atrial fibrillation
Incidence of postoperative complications
Blood pressure, heart rate
Inflammatory index: WBC, CRP, IL-6, HMGB-1
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Intravenous placebo Glucose 5% after operation.
Intravenous landiolol hydrochloride after operation, 3 gamma, 72 hr.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Toshiyasu Ojima |
Wakayama Medical University
Second Department of Surgery
811-1, Kimiidera, Wakayama 641-8510, Japan
073-441-0613
tojima@wakayama-med.ac.jp
1st name | |
Middle name | |
Last name | Toshiyasu Ojima |
Wakayama Medical University
Second Department of Surgery
811-1, Kimiidera, Wakayama 641-8510, Japan
073-441-0613
tojima@wakayama-med.ac.jp
Second Department of Surgery, Wakayama Medical University, School of Medicine
Second Department of Surgery, Wakayama Medical University, School of Medicine
Other
NO
2013 | Year | 05 | Month | 04 | Day |
Unpublished
Completed
2013 | Year | 04 | Month | 01 | Day |
2013 | Year | 04 | Month | 01 | Day |
2016 | Year | 04 | Month | 01 | Day |
2013 | Year | 05 | Month | 04 | Day |
2016 | Year | 02 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012452
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