UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Useflness of LigaSure and Harmonic in liver transection
Title of the study (Brief title)	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	Norihiro Kokudo
Organization	The University of Tokyo
Division name	Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine
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	Akihiko Ichida, Kiyoshi Hasegawa
Organization	The University of Tokyo
Division name	Hepato-biliary-pnacreatic Surgery Division, Department of Surgery, Graduate School of Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009827