UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the safety of laparoscopic liver surgery Multicenter prospective study
Title of the study (Brief title)	Verification of the safety of laparoscopic liver surgery
Region	Japan

Condition
Condition	Liver tumor
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Verification of the safety of laparoscopic liver surgery
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Duration of surgery
Key secondary outcomes	Blood loss Conversion rate Postoperative morbidity Mortality Re-operation rate Postoperative hospital stay etc

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Candidates for laparoscopic liver surgery
Key exclusion criteria	Patients with cognitive impairment or consciousness disorder
Target sample size	100

Research contact person
Name of lead principal investigator	Satoru Seo
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Surgery
Address	54 Kawaharacho, Shogoin, Sakyoku, Kyoto
TEL	075-751-3242
Email	rutosa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Hiroaki Fuji
Organization	Graduate School of Medicine, Kyoto University
Division name	Department of Surgery
Address	54 Kawaharacho, Shogoin, Sakyoku, Kyoto
TEL	075-751-3242
Homepage URL
Email	fhiro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
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	2016 Year 07 Month 29 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 04 Month 23 Day
Anticipated trial start date	2015 Year 05 Month 11 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	multicenter prospective study

Management information
Registered date	2016 Year 07 Month 28 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026928