UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008372 |
|---|---|
| Receipt number | 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 09:36:50 |
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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
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
ichida-tky@umin.ac.jp
Sponsor or person
Institute
Hepato-biliary-pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009827
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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