UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020234 |
|---|---|
| Receipt number | R000023370 |
| Scientific Title | A randomized controlled trial of pure laparoscopic versus open hepatectomy for liver tumor |
| Date of disclosure of the study information | 2015/12/17 |
| Last modified on | 2017/06/20 19:55:00 |
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Basic information
Public title
A randomized controlled trial of pure laparoscopic versus open hepatectomy for liver tumor
Acronym
RCT of pure laparoscopic vs open hepatectomy
Scientific Title
A randomized controlled trial of pure laparoscopic versus open hepatectomy for liver tumor
Scientific Title:Acronym
RCT of pure laparoscopic vs open hepatectomy
Region
| Japan |
Condition
Condition
Liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and feasibility of laparoscopic versus open hepatectomy for liver tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood loss
Key secondary outcomes
complication, operation time, hospital stay, margin, QOL
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with liver tumor randomly are assigned to open hepatoctomy or pure laparoscopic hepatectomy.
Interventions/Control_2
Patients with liver tumor randomly are assigned to open hepatoctomy or pure laparoscopic hepatectomy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Liver tumor with surgical indication (partial hepatectomy or lateral segmentectomy)
2) maximum tumor diameter is less than 5 cm, less than 3 nodules
3) 20 years old or more
4) ECOG Performance status of 0 or 1
5) Child-Pugh classification A or B
6) Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements.
WBC >= 2000/uL, Neutrophil >= 1000/uL, Hemoglobin >= 8.5 g/dL, Platelet count >= 70000/uL, Total Bilirubin <= 1.5mg/dl, AST/ALT <= 150 IU/L, Serum creatinine <= 1.5mg/dL
7) written informed consent
Key exclusion criteria
1) planning combined resection of other organ
2) History of upper abdominal surgery or hepatectomy
3) Severee complications (IP, HF, RF, LF, ileus, DM, etc)
4) Pregnancy
5) participate in another clinical trial
6) others, in the investigator's judgment
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, E-2, Yamadaoka, Suita, Osaka, Japan
TEL
+81668793251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Noda |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2, E-2, Yamadaoka, Suita, Osaka, Japan
TEL
+81668793251
Homepage URL
tnoda@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Clinical Study Group of Osaka University (CSGO)
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
| 2015 | Year | 12 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | 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
| 2015 | Year | 12 | Month | 16 | Day |
Last modified on
| 2017 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023370
