UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of liver resection assisted by laparoscopic approach for liver mobilization and/or transection
Acronym	Efficacy of laparoscopy-assisted liver resection
Scientific Title	Efficacy of liver resection assisted by laparoscopic approach for liver mobilization and/or transection
Scientific Title:Acronym	Efficacy of laparoscopy-assisted liver resection
Region	Japan

Condition
Condition	Hepatobiliary diseases
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate efficacy of liver resection assisted by laparoscopic approach for liver mobilization and/or transection
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intraoperative blood loss
Key secondary outcomes	Short-term results, pain scale, patients' satisfaction survey

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Liver resection assisted by laparoscopic approach
Interventions/Control_2	Open liver resection without laparoscopic approach
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are to undergo liver resection for hepatobiliary benign or malignant diseases.
Key exclusion criteria	Severe adhesion, severe cardiopulmonary diseases, contraindications of pneumoperitoneum.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Takeaki Middle name Last name Ishizawa
Organization	Graduate School of Medicine, the University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code	113-0022
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	0338155411
Email	tish-tky@umin.ac.jp

Public contact
Name of contact person	1st name Takeaki Middle name Last name Ishizawa
Organization	Graduate School of Medicine, the University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code	1138655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	0338155411
Homepage URL
Email	tish-tky@umin.ac.jp

Sponsor
Institute	Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, the University of Tokyo
Institute
Department

Funding Source
Organization	the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	IRB of the University of Tokyo Hospital
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel	03-5800-8743
Email	crctky-office@umin.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	2012 Year 10 Month 31 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007%2Fs00268-021-05992-x
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007%2Fs00268-021-05992-x
Number of participants that the trial has enrolled	165
Results	We categorized 165 patients into LAP (n=9, 5%), MID (n=21, 13%), J (n=95, 58%), and TRC (n=40, 24%) groups. Median VAS (visual analog scale) scores on PODs 3/7/30/90 were: LAP, 27.5/7.5/10/10; MID, 30/10/15/5; J, 50/27.5/20/10, and TRC, 50/30/30/19. The J and TRC groups had significantly higher VAS scores vs. MID on PODs 3 and 7. Physical QOL summary scores did not return to preoperative levels even on POD 90, in patients with an additional transverse incision.
Results date posted	2021 Year 05 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Patients undergoing hepatectomy
Participant flow	Subjects are classified into the 4 groups according to surgical approaches
Adverse events	Perioperative complications, surgery-related mortality
Outcome measures	Morbidity, operative outcomes, postoperative pain, postoperative QOL
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 09 Day
Date of IRB	2012 Year 07 Month 26 Day
Anticipated trial start date	2012 Year 10 Month 01 Day
Last follow-up date	2015 Year 09 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	2012 Year 10 Month 30 Day
Last modified on	2021 Year 05 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010822