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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017467
Receipt No. R000019644
Scientific Title Evaluation of the efficacy of laparoscopic approach in operative outcomes after liver resection
Date of disclosure of the study information 2015/05/11
Last modified on 2015/05/08

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Basic information
Public title Evaluation of the efficacy of laparoscopic approach in operative outcomes after liver resection
Acronym Efficacy of laparoscopic approach during liver resection
Scientific Title Evaluation of the efficacy of laparoscopic approach in operative outcomes after liver resection
Scientific Title:Acronym Efficacy of laparoscopic approach during liver resection
Region
Japan

Condition
Condition Subjects consist of patients undergoing liver resection for hepato-biliary marignancies.
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of using laparoscopic techniques for liver mobilization and/or hepatic transection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of operative blood loss
Key secondary outcomes Postoperative outcomes

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 Laparoscopic group: Use of laparoscopic techniques for liver mobilization and/or parenchymal transection
Interventions/Control_2 Open group: No use of laparoscopic approach during hepatectomy procedures
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 Patients were diagnosed with resectable hepato-biliary malignancies for example primary liver cancer, metastatic liver cancer, hepatic hemangioma, hepatic adenoma, bile duct cancer or intraductal papillary neoplasm of bile duct.
Key exclusion criteria excluding criteria common to both groups
1.cardiopulmonary function disorder.
2.Those who are judged unable to withstand surgery by the investigators with the preoperative assessment

excluding criteria specialized in laparoscopy assisted group
1.expecte severe adhesion in abdominal cavity
2.contraindication for pneumoperitoneum, for example closed angle glaucoma, intracranial hypertension or severe emphysema.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Kokudo
Organization University of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address 7-3-1Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL +81-3-5800-8841
Email KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeaki Ishizawa
Organization university of Tokyo
Division name Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address 7-3-1Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL +81-3-5800-8841
Homepage URL
Email tish-tky@umin.ac.jp

Sponsor
Institute University of Tokyo
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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 東京大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 11 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 No longer recruiting
Date of protocol fixation
2012 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 08 Day
Last modified on
2015 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019644

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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