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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010731
Receipt No. R000012542
Scientific Title Laparoscopy-assisted hepatectomy using the radio frequency ablation system: A multicenter trial
Date of disclosure of the study information 2013/05/15
Last modified on 2013/05/15

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Basic information
Public title Laparoscopy-assisted hepatectomy using the radio frequency ablation system: A multicenter trial
Acronym Laparoscopy-assisted hepatectomy
Scientific Title Laparoscopy-assisted hepatectomy using the radio frequency ablation system: A multicenter trial
Scientific Title:Acronym Laparoscopy-assisted hepatectomy
Region
Japan

Condition
Condition Primary liver cancer, Metastatic liver cancer and Benign liver disease
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of laparoscopy-assisted major liver resections.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraoperative blood loss
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Laparoscopy-assisted hepatectomy
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Case of the patient needs laparoscopy-assisted major hepatectomy for HCC, metastatic liver cancer, and benign disease.
Key exclusion criteria The patient had tumors 10 cm in diameter and are not undergoing bile duct resection or lymph node dissection. Patients with lesions involving the diaphragm or inferior vena cava were excluded.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Go Wakabayashi
Organization Iwate Medical University School of Medicine
Division name Surgery
Zip code
Address 19-1, Uchimaru, Morioka, Iwate, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Iwate Medical University School of Medicine
Division name Surgery
Zip code
Address
TEL 019-651-5111
Homepage URL
Email

Sponsor
Institute Iwate Medical University School of Medicine
Institute
Department

Funding Source
Organization Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
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
2013 Year 05 Month 15 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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 15 Day
Last modified on
2013 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012542

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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