UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009220 |
|---|---|
| Receipt number | R000010822 |
| Scientific Title | Efficacy of liver resection assisted by laparoscopic approach for liver mobilization and/or transection |
| Date of disclosure of the study information | 2012/10/31 |
| Last modified on | 2021/05/07 13:11:02 |
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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
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
tish-tky@umin.ac.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, the University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010822
