Unique ID issued by UMIN | UMIN000005325 |
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Receipt number | R000006329 |
Scientific Title | A prospective randomized controlled trial of two different for hepatic transection: cavitron ultrasonic surgical aspirator with irrigating bipolar electrocautery versus cavitron ultrasonic surgical aspirator with radiofrequency bipolar sealer |
Date of disclosure of the study information | 2011/04/01 |
Last modified on | 2012/03/27 10:40:33 |
A prospective randomized controlled trial of two different for hepatic transection: cavitron ultrasonic surgical aspirator with irrigating bipolar electrocautery versus cavitron ultrasonic surgical aspirator with radiofrequency bipolar sealer
CUSA with bipolar cautery vs. CUSA with radiofrequency bipolar sealer for hepatic transaction
A prospective randomized controlled trial of two different for hepatic transection: cavitron ultrasonic surgical aspirator with irrigating bipolar electrocautery versus cavitron ultrasonic surgical aspirator with radiofrequency bipolar sealer
CUSA with bipolar cautery vs. CUSA with radiofrequency bipolar sealer for hepatic transaction
Japan |
A case who need to hepatic resection for primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, hilar cholangiocellular carcinoma, metastatic liver cancer, and transplantational donor).
Hepato-biliary-pancreatic surgery |
Malignancy
NO
The aim of this study is to compare the cavitron ultrasonic surgical aspirator (CUSA) with irrigating bipolar electrocautery to CUSA with a radiofrequency bipolar sealer [TissuLink ™] in terms of efficacy and safety for hepatic transaction in cases who need to hepatic resection for primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, hilar cholangiocellular carcinoma, metastatic liver cancer, and transplantational donor.
Efficacy
Confirmatory
Pragmatic
Phase III
Blood loss during parenchymal transaction and speed of transaction
The degree of postoperative liver injury and morbidity
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
YES
NO
2
Treatment
Device,equipment |
CUSA with irrigating bipolar electrocautery
CUSA with a radiofrequency bipolar sealer [TissuLink ™]
20 | years-old | <= |
Not applicable |
Male and Female
1)no preceded treatment
2)no extrahepatic lesion or major vascular invasion
3)performance status 0-2
4) bone marrow function and
hepatic/renal functions are well
maintained
a)White blood cell count: 2000-
10000/mm3
b)Platelet count of 50000/mm3 or more
c)Hemoglobin of 8.0g/dL or more
d)Serum total bilirubin of 2.0mg/dL or
less
e)Prothronbin time of 50% or more
f)Serum creatinine of 1.5mg/dL or less
g)Blood urea nitrogen of 35mg/dL or less
1) Double cancer or history of other
malignancy within 5 years after diagnosis
2) History of myocardial infarction or
unstable angina within 6 months prior to
registration
3) Patient with interstitial pneumonia,
pneumofibrosis, or severe lung
emphysema
4) Patient who cannot undergo enhanced
CT scan due to some reason such as
allergy for iodized contrast media or
renal dysfunction
5) Patient with psychiatric disorder or
symptom
6) Pregnant patient or patient with
possibility to be pregnant
100
1st name | |
Middle name | |
Last name | Masaki Kaibori |
Kansai Medical University
Department of Surgery
2-3-1Shinmachi, Hirakata city, Osaka
072-804-0101
1st name | |
Middle name | |
Last name | Masaki Kaibori |
Kansai Medical University
Department of Surgery
2-3-1Shinmachi, Hirakata city, Osaka
072-804-0101
kaibori@hirakata.kmu.ac.jp
Department of Surgery, Kansai Medical Univedrsity
none
Other
NO
2011 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2011 | Year | 04 | Month | 01 | Day |
2011 | Year | 04 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
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2012 | Year | 04 | Month | 01 | Day |
2011 | Year | 03 | Month | 27 | Day |
2012 | Year | 03 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006329
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