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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005325
Receipt No. 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

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Basic information
Public 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
Acronym CUSA with bipolar cautery vs. CUSA with radiofrequency bipolar sealer for hepatic transaction
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
Scientific Title:Acronym CUSA with bipolar cautery vs. CUSA with radiofrequency bipolar sealer for hepatic transaction
Region
Japan

Condition
Condition A case who need to hepatic resection for primary hepatocellular carcinoma, intrahepatic cholangiocarcinoma, gallbladder cancer, hilar cholangiocellular carcinoma, metastatic liver cancer, and transplantational donor).
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Blood loss during parenchymal transaction and speed of transaction
Key secondary outcomes The degree of postoperative liver injury and morbidity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 CUSA with irrigating bipolar electrocautery
Interventions/Control_2 CUSA with a radiofrequency bipolar sealer [TissuLink ™]
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

Not applicable
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Kaibori
Organization Kansai Medical University
Division name Department of Surgery
Zip code
Address 2-3-1Shinmachi, Hirakata city, Osaka
TEL 072-804-0101
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Kaibori
Organization Kansai Medical University
Division name Department of Surgery
Zip code
Address 2-3-1Shinmachi, Hirakata city, Osaka
TEL 072-804-0101
Homepage URL
Email kaibori@hirakata.kmu.ac.jp

Sponsor
Institute Department of Surgery, Kansai Medical Univedrsity
Institute
Department

Funding Source
Organization none
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
2011 Year 04 Month 01 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
2011 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 03 Month 01 Day
Date analysis concluded
2012 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 27 Day
Last modified on
2012 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006329

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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