UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000337 |
|---|---|
| Receipt number | R000000424 |
| Scientific Title | Randomized controlled trial to evaluate the effects of the surgical instrument LigaSure on reduction of time of liver transection time, compared with the conventional clamp crushing method at the single institution |
| Date of disclosure of the study information | 2006/02/24 |
| Last modified on | 2006/12/15 21:50:05 |
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Basic information
Public title
Randomized controlled trial to evaluate the effects of the surgical instrument LigaSure on reduction of time of liver transection time, compared with the conventional clamp crushing method at the single institution
Acronym
Randomized controlled trial to evaluate the effects of LigaSure concerning liver transection time
Scientific Title
Randomized controlled trial to evaluate the effects of the surgical instrument LigaSure on reduction of time of liver transection time, compared with the conventional clamp crushing method at the single institution
Scientific Title:Acronym
Randomized controlled trial to evaluate the effects of LigaSure concerning liver transection time
Region
| Japan |
Condition
Condition
Patients undergoing liver resection.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial is to evaluate the effects of the new hopeful surgical instrument (LigaSure) on liver transection time in hepatectomy, compared with the convetional clamp crushing method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Liver transection time in hepatectomy
Key secondary outcomes
Transection area per minute, total operation time, total amount of bleeding, amount of bleeding during transection, amount of transfusion, incidence of bile leakage, postoperative bleeding, incidence of pleural effusion/ascites, hospital stay, postoperative iver function, total bilirubin value of the drained discharge
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Liver transcetion using LigaSure
Interventions/Control_2
Liver transection by the clamp crushing method
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients, who are 20-85 years old. scheduled to undergo hepatectomy at our institution, provide a written informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria
1.Simultaneous development of other malignant disease (except a colorectal carcinoma associated with liver metastasis)
2.Cases with high-risks of bleeding, for example; platele counts < 50000/mm3, bleeding time > 5min., PT% < 50%
3.Cases in which inflow occulusion is impossible.
4.Cases with bilio-enteric reconstruction
5.Emergency operation case
6.Cases with some complications of heart, lung, and kidney.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Makuuchi |
Organization
University of Tokyo, Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, The Artificial Organ and Transplantation Division, Department of Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8654
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mami Ikeda |
Organization
University of Tokyo, Tokyo University Hospital
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-5800-8654
Homepage URL
ikemami-ind@umin.ac.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Tokyo University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 02 | Month | 24 | 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
| 2006 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2006 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 01 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 02 | Month | 24 | Day |
Last modified on
| 2006 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000424
