UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001158 |
|---|---|
| Receipt number | R000001408 |
| Scientific Title | Laparoscopy-assisted hepatectomy |
| Date of disclosure of the study information | 2008/05/15 |
| Last modified on | 2008/05/15 17:15:07 |
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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
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
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001408
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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