UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The introduction of laparoscopy assisted hepatectomy in living donor surgery
Title of the study (Brief title)	Laparoscopy assisted hepatectomy in living donor surgery
Region	Japan

Condition
Condition	Live donor for liver transplant
Classification by specialty	Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will compare and evaluate the safety and the minimal invasiveness between conventional donor liver surgery and laparoscopy-assisted donor liver surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Operative data(operation time, blood loss), the details of postoperative complications, wound pain meter by Numerical Rating Scale and MPQ , QOL 1 year after donor operation by SF-36
Key secondary outcomes

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	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	1) After inserting the port (12mm) from navel, and two ports from the right lower abdomen, the mobilization of right and left lobe of liver will be performed. 2) Laparotomy will be performed via small midline incision, 10-12cm in a diameter. Donor liver surgery will be performed from small incision, as same as the conventional method. 3) After the completion of hepatectomy, liver grafts will be procured from small incisions.
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	18 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	all live donors for transplantation
Key exclusion criteria	the cases without the authorization of this study
Target sample size	50

Research contact person
Name of lead principal investigator	Norio Yoshimura
Organization	Kyoto Prefectural University of medicine
Division name	Department of Transplant and General surgery
Address	465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, Japan
TEL	075-251-5532
Email	orgtx@koto.kpu-m.ac.jp

Public contact
Name of contact person	Taku Iida
Organization	Kyoto Prefectural University of medicine
Division name	Department of Transplant and General surgery
Address	465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, Japan
TEL	075-251-5532
Homepage URL	http://www.f.kpu-m.ac.jp/k/orgtx/
Email	itaku@koto.kpu-m.ac.jp

Sponsor
Institute	Kyoto Prefectural University of medicine
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	self funding
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 08 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 03 Day
Anticipated trial start date	2016 Year 08 Month 22 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	2016 Year 07 Month 25 Day
Last modified on	2016 Year 07 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026867