UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023328 |
|---|---|
| Receipt number | R000026867 |
| Scientific Title | The introduction of laparoscopy assisted hepatectomy in living donor surgery |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2016/07/25 21:34:47 |
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Basic information
Public title
The introduction of laparoscopy assisted hepatectomy in living donor surgery
Acronym
Laparoscopy assisted hepatectomy in living donor surgery
Scientific Title
The introduction of laparoscopy assisted hepatectomy in living donor surgery
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Norio Yoshimura |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Transplant and General surgery
Zip code
Address
465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, Japan
TEL
075-251-5532
orgtx@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Iida |
Organization
Kyoto Prefectural University of medicine
Division name
Department of Transplant and General surgery
Zip code
Address
465 Kajiicho Hirokoji Kawaramachi Kamigyo-ku, Kyoto, Japan
TEL
075-251-5532
Homepage URL
http://www.f.kpu-m.ac.jp/k/orgtx/
itaku@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of medicine
Institute
Department
Personal name
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)
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
| 2016 | Year | 08 | Month | 01 | 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
| 2016 | Year | 08 | Month | 03 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026867
