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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000337
Receipt No. 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

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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
Email

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
Email ikemami-ind@umin.ac.jp

Sponsor
Institute Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Tokyo University Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000424

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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