UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034341 |
|---|---|
| Receipt number | R000039140 |
| Scientific Title | Exploratory study of Laparoscopic Navigation System with Real-time Virtual Sonography |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2026/04/21 21:39:03 |
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Basic information
Public title
Exploratory study of Laparoscopic Navigation System with Real-time Virtual Sonography
Acronym
A Novel Intraoperative Navigation System for Laparoscopic Liver Resection Using Real-Time Virtual Sonography
Scientific Title
Exploratory study of Laparoscopic Navigation System with Real-time Virtual Sonography
Scientific Title:Acronym
A Novel Intraoperative Navigation System for Laparoscopic Liver Resection Using Real-Time Virtual Sonography
Region
| Japan |
Condition
Condition
Exploratory study
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the differences between the simulated dissecting domain and the authentic dissecting domain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The differences between the simulated dissecting domain and the authentic dissecting domain are within 10mm in mean.
Key secondary outcomes
Evaluated factors are within the tolerance range.
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Scheduled hepatic resection with preoperative images with computed tomography or magnetic resonance imaging, (2) Performance status 0 or 1, (3) The following standards of marrow functions: white blood cell count>/=3500mm3, haemoglobn>/=10.0g/dl, Platelet>/=80000/mm3, (4) The following standards of liver functions: total bilirubin level<2.0mg/dl, aspartate aminotransferase level<100U/l, alanine aminotransferase<100U/l, liver damage A or B.
Key exclusion criteria
apprication withdrawal
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | none |
| Last name | Sakata |
Organization
Japan Seafares Relief Association Ekisaikai Moji Hospital
Division name
Surgery
Zip code
801-0833
Address
1-3-1 Kiyotaki Mojiku Kitakyushu Fukuoka, 801-8505
TEL
093-321-0984
atak51ks331007@gmail.com
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | none |
| Last name | Koichiro Sakata |
Organization
Japan Seafares Relief Association Ekisaikai Moji Hospital
Division name
Surgery
Zip code
801-8550
Address
1-3-1 Kiyotaki Mojiku Kitakyushu Fukuoka, Japan, 801-8505
TEL
093-321-0984
Homepage URL
https://ekisaikai-moji.com/
atak51ks331007@gmail.com
Sponsor or person
Institute
JCHO Shimonoseki Medical Center
Institute
Department
Personal name
Koichiro Sakata
Funding Source
Organization
Hitachi Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Japan Seafares Relief Association Ekisaikai Moji Hospital
Address
1-3-1 Kiyotaki Mojiku Kitakyushu Fukuoka, Japan, 801-8505
Tel
0933210984
atak51ks331007@gmail.com
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
Japan Seafares Relief Association Ekisaikai Moji Hospital(Fukuoka), JCHO Shimonoseki Medical Center(Yamaguchi)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
on paper
Publication of results
Partially published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC7148355/pdf/41598_2020_Article_63131.pdf
Number of participants that the trial has enrolled
4
Results
During in vitro demonstration, the errors of 33 cm and 13 cm distance setting from the tip of the electrocautery revealed the error 7.8 +/=-3.5 mm (mean +/- Standard Deviation), and 3.3 +/- 1.0 mm, respectively (P < 0.05).
The mean differences of the dissection plane between the simulation and conventional procedures were 2.0 mm, 1.5 mm, 8.2 mm, and 4.3 mm, respectively.
Results date posted
| 2026 | Year | 04 | Month | 08 | Day |
Results Delayed
Results Delay Reason
not available
Date of the first journal publication of results
| 2020 | Year | 04 | Month | 10 | Day |
Baseline Characteristics
An in vitro demonstration of the 3D pronter model, and in vivo demonstration in four patients with hepatic malignancies were preliminarily investigated in this study between January 2017 and Decenber 2017. Patients who met the following criteria were included in the study: Patients aged 20-80 years at the time of agreement acquisition, patients who were scheduled for hepatic resection with preoperative images of computed tomography or magnetic imaging, patients who had performance status 0 or 1, and patients who had the following standards of marrow functions, and the following atandards of liver functions, liver damage A or B.
Participant flow
In vivo demonstration in four patients with hepatic malignancies were preliminarily investigated in this study between January 2017 and December 2017.
Adverse events
No harmful event occurred after surgery and post-operative changes of liver function met the tolerance level.
Outcome measures
Duration of actual liver transection times were calculated, using the video recording system, as 148, 59, 69 and 90 minutes for case 1, 2, 3, and 4, respectively.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
The differences between the simulation plane and the authentic plane were conventionally investigated after dividing the surrounding ligaments laparoscopically. The authentic dissecting plane was estimated by a staining method with contrast-enhancement ultrasonography and near-infrared ray vision system (Photo Dynamic Rye(R), HAMAMATSU Photonics). The differences were measured as a request of errors detected every 5 degrees of the plane image from the center in in a real excision domain.
Management information
Registered date
| 2018 | Year | 10 | Month | 01 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039140
