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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008372
Receipt No. R000009827
Scientific Title Useflness of LigaSure and Harmonic in liver transection
Date of disclosure of the study information 2012/07/06
Last modified on 2017/01/08

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Basic information
Public title Useflness of LigaSure and Harmonic in liver transection
Acronym Useflness of LigaSure and Harmonic in liver transection
Scientific Title Useflness of LigaSure and Harmonic in liver transection
Scientific Title:Acronym Useflness of LigaSure and Harmonic in liver transection
Region
Japan

Condition
Condition Primary malignant liver tumor including hepatocellular carcinoma, intrahepatic bile duct cancer, combined hepatocellular-cholangiocarcinoma. Metastatic liver tumor.
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the usefulness of LigaSure and Harmonic in liver transection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of bleeding during liver transection
Key secondary outcomes Total transection time, Cross-sectional area per minute, Operative duration, Postoperative complications, Postoperative liver function, Length of hospital stay

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 Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 In the intervention group, the liver transection is performed using LigaSure.
Interventions/Control_2 In the intervention group, the liver transection is performed using Harmonic.
Interventions/Control_3 In the control group, the liver transection is performed using conventional clamp crushing method.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients who will undergo hepatic resection for malignant liver tumor
2)ECOG Performance Status 0-2
3)Patients who meet the Makuuchi criteria
Key exclusion criteria 1)Donor of liver transplantation
2)Patients who will undergo biliary tract reconstruction
3)Patients who will undergo resection of the gastrointestinal tract at the same time
4)Patients with simultaneous double cancer
5)When the clamping of hepatoduodenal ligament is expected to be difficult
6)Possibility of exploratory laparotomy
7)Patients with severe complications
8)Patients who were deemed inappropriate for medical reasons
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization The University of Tokyo
Division name Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email kokudo-2su@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiko Ichida, Kiyoshi Hasegawa
Organization The University of Tokyo
Division name Hepato-biliary-pnacreatic Surgery Division, Department of Surgery, Graduate School of Medicine
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email ichida-tky@umin.ac.jp

Sponsor
Institute Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization Self funded
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Gastrointestinal Surgery, Nihon University
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 東京大学医学部附属病院(東京都)、日本大学医学部附属板橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

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
2012 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2014 Year 06 Month 01 Day
Date of closure to data entry
2014 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 07 Month 06 Day
Last modified on
2017 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009827

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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