UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial of pure laparoscopic versus open hepatectomy for liver tumor
Title of the study (Brief title)	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	Hidetoshi Eguchi
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
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	Takehiro Noda
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Gastroenterological Surgery
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 12 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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