UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010731 |
|---|---|
| Receipt number | 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 19:36:26 |
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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
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
Sponsor or person
Institute
Iwate Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012542
