UMIN-CTR Clinical Trial

Basic information
Public title	Randomized controlled trial of open vs laparoscopic re-hepatectomy for recurrent liver cancer
Acronym	RCT of open vs laparoscopic re-hepatectomy for recurrent liver cancer
Scientific Title	Randomized controlled trial of open vs laparoscopic re-hepatectomy for recurrent liver cancer
Scientific Title:Acronym	RCT of open vs laparoscopic re-hepatectomy for recurrent liver cancer
Region	Japan

Condition
Condition	Recurrent liver cancer with the indication for re-hepatectomy (hepatocellular carcinoma, combined liver cancer or metastatic liver cancer)
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aims is to access the short-term surgical outcomes open re-hepatectomy and laparoscopic re-hepatectomy for recurrent liver cancer (hepatocellular carcinoma, combined liver cancer or metastatic liver cancer)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	intraopearative blood loss
Key secondary outcomes	complication rate, operation time, period of hospital stay, surgical margin and conversion rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Laparoscopic re-hepatactomy
Interventions/Control_2	Open re-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. The patients with liver cancer for re-hepatectomy 2. The patients with history of laparoscopic or open hepatectomy 3. The maximum size under 5cm and the number of tumor under 3 lesions 4. Over 20 years old 5. ECOG performance status is 0 or 1 6. Child-Pugh score is under 7 7. The functions of major organs are preserved before 28 days before registration. 8. Written informed and consent
Key exclusion criteria	1) combined resection of other organs excluded for gallbladder. 2) Serious complication of ileus, interstitial pneumonia, pulmonary fibrosis, uncontrollable diabetes, heart failure, renal failure, liver failure, active ulcer or varix, severe mental disorder and depression 3) Women who are pregnant or have the potential of pregnancy and lactating. 4) The patients enrolled for other trial with same primary endpoint. 5) The investigator judged to be unsuitable for this study.
Target sample size	54

Research contact person
Name of lead principal investigator	1st name Hidetoshi Middle name Last name Eguchi
Organization	Osaka University, Department of Gastroenterological Surgery
Division name	CSGO
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3251
Email	heguchi@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Takehiro Middle name Last name Noda
Organization	Osaka University, Department of Gastroenterological Surgery
Division name	CSGO
Zip code	5650871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3251
Homepage URL
Email	tnoda@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University, Department of Gastroenterological Surgery
Institute
Department

Funding Source
Organization	Osaka University, Department of Gastroenterological Surgery
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	IRB of Osaka University Hospital
Address	2-2 Yamadaoka, Suita, Osaka
Tel	06-6210-8289
Email	rinri@hp-crc.med.osaka-u.ac.jp

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	2019 Year 06 Month 20 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	Preinitiation
Date of protocol fixation	2019 Year 06 Month 18 Day
Date of IRB
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2024 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 18 Day
Last modified on	2019 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042269