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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001158
Receipt No. R000001408
Scientific Title Laparoscopy-assisted hepatectomy
Date of disclosure of the study information 2008/05/15
Last modified on 2008/05/15

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Basic information
Public title Laparoscopy-assisted hepatectomy
Acronym Laparoscopy-assisted hepatectomy
Scientific Title Laparoscopy-assisted hepatectomy
Scientific Title:Acronym Laparoscopy-assisted hepatectomy
Region
Japan

Condition
Condition Primary hepatic cancer
Metastatic liver cancer
Benign liver disease
Doner
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim for this study is to assess the safety and surgical outcome of laparoscopy-assisted hepatectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Postoperative hospital stay
Key secondary outcomes Operation time
Blood loss

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Surgical procedure
Cholecystectomy and mobilization of the liver are performed with pneumoperitoneum. Before starting liver resection, pneumoperitoneum is quitted to avoid possible CO2 embolism through the cut surface of the liver. An 8-12cm of sub-costal mini-laparotomy is made, and intra-operative ultrasonogram is performed to identify all the major vessels and bile ducts. We start to ligate the hepatic pedicle before parenchymal dissection. Hepatic parenchymal dissection is performed through the mini-laparotomy with a laparoscopic coagulating scissors and an ultrasonic dissector using the liver-hanging maneuver. The hepatic pedicle, short hepatic veins, and the hepatic vein are divided with GIA stapling. In donor hepatectomy, first perform parenchymal resection and then divide the bile duct, hepatic artery, portal vein and hepatic vein.
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

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Indication for laparoscopy-assisted hepatectomy includes tumor size less than 10cm without bile duct resection or lymph node dissection.
Key exclusion criteria All except key inclusion criteria
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Go wakabayashi
Organization Iwate Medical University
Division name Surgery
Zip code
Address 19-1 Uchimaru,Morioka,Iwate Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Nitta
Organization Iwate Medical University
Division name Surgery
Zip code
Address 19-1 Uchimaru,Morioka,Iwate Japan
TEL
Homepage URL
Email

Sponsor
Institute Iwate Medical University
Institute
Department

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)

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

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 15 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
2008 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2013 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 05 Month 15 Day
Last modified on
2008 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001408

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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