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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020234
Receipt No. 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

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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
Email 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
Email tnoda@gesurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterological Surgery, Graduate School of Medicine, Osaka University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023370

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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