UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043358 |
|---|---|
| Receipt number | R000049483 |
| Scientific Title | Exploratory Report: "Initial Report: A Unique Three-Dimensional Elastic Liver Model with Emulator Functionality; Evaluation to the theme that the Simulation Model Assisting Resection Technique of Liver (SMART Liver) has an emulation function" |
| Date of disclosure of the study information | 2021/02/23 |
| Last modified on | 2021/02/19 11:21:55 |
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Basic information
Public title
Evaluation to the theme that the Simulation Model Assisting Resection Technique of Liver (SMART Liver) has an emulation function
Acronym
E-SMART Liver
Scientific Title
Exploratory Report: "Initial Report: A Unique Three-Dimensional Elastic Liver Model with Emulator Functionality; Evaluation to the theme that the Simulation Model Assisting Resection Technique of Liver (SMART Liver) has an emulation function"
Scientific Title:Acronym
Exploratory Report: E-SMART Liver
Region
| Japan |
Condition
Condition
hepatic disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In hepatic treatment, high-level skills and experience are indispensable. Preoperative simulations have become a valid approach and are widely used. However, at present, it is complicated to perform physical simulations on simulated images with real-time liver deformity requires a lot of calculations and to simultaneously reproduce the nonrigid registration of the liver with elasticity on the monitor during surgery. Therefore, this study aimed to develop a patient-specific 3D liver model (Simulation Model Assisting Resection Technique of Liver, or SMART Liver) to reproduce in vivo conditions and to enable preoperative simulations, including nonrigid registration.
The 3DLM's validity were investigated by questionnaire survey to doctors engaged in liver treatment.
After the initial physical simulation with SMART Liver, the learning curve of sequential laparoscopic lateral sectionectomy operations performed by one operator was investigated retrospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Theme that the 3D model has an emulation function in teaching residents were investigated on a 5-point scale (5: excellent; 4: good; 3: fair; 2: poor; 1: unacceptable) after watching an instructional video
1) reproducibility
the images obtained from the 3D model properly depict information
transparency
tolerability of imaging devices (ultrasonography)
tolerability of imaging devices (CT)
appropriate for training the therapeutic techniques (real-time virtual sonography, puncture technique, interventional approach)
appropriate for training the therapeutic techniques (puncture technique)
appropriate for training the therapeutic techniques (interventional approach)
appropriate for training the therapeutic techniques (laparoscopic lateral sectionectomy)
Key secondary outcomes
Number of cases to reach the appropriate operative time on the learning curve.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Instructing doctors
Interventions/Control_2
Practitioner
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) Questionnaire survey target doctors
Doctors involved in liver treatment.
2) Patients undergoing laparoscopic lateral sectionectomy of liver
(1) Performance status 0 or 1
(2) Patients who meet the following criteria and have bone marrow function that can appropriately evaluated safety
a) White blood cells >/= 3500 /mm2
b) Hemoglobin >/= 10.0 g/dl
c) Platelets >/= 100000 /mm2
(3) Patients who met the following criteria and have liver function that can appropriately evaluated safety.
a) Total serum bilirubin < 2.0mg/dl
b) AST < 100 IU/L
c) ALT < 100 IU/L
d) ICG stagnation rate at 15 minutes < 20 %
e) PT > 80 %
f) Ascites: None
g) Hepatic encephalopathy: None
Key exclusion criteria
2) Patients undergoing laparoscopic lateral sectionectomy of liver
(1) Patients with a history of upper abdominal surgery
(2) Patients with severe renal damage
(3) Patients with bleeding tendency
(4) Patients who are judged to be inappropriate for this study by the doctor or the attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | KOICHIRO |
| Middle name | |
| Last name | SAKATA |
Organization
Japan Seafarers Relief Association Moji Ekisaikai Hospital
Division name
Surgery
Zip code
801-8550
Address
1-3-1 Kiyotaki Mojiku, Kitakyushu city, Fukuoka, Japan
TEL
+81-093-321-0984
atak51ks331007@gmail.com
Public contact
Name of contact person
| 1st name | KOICHIRO |
| Middle name | |
| Last name | SAKATA |
Organization
Japan Seafarers Relief Association Moji Ekisaikai Hospital
Division name
Surgery
Zip code
801-8550
Address
1-3-1 Kiyotaki Mojiku, Kitakyushu city, Fukuoka, Japan
TEL
+81-093-321-0984
Homepage URL
atak51ks331007@gmail.com
Sponsor or person
Institute
Japan Seafarers Relief Association Moji Ekisaikai Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitakyushu Medical Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Seafarers Relief Association Moji Ekisaikai Hospital
Address
1-3-1 Kiyotaki Mojiku, Kitakyushu city, Fukuoka, Japan
Tel
+81-093-321-0984
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
北九州市立医療センター（福岡）、北九州市立八幡病院（福岡）、一般社団法人平成紫川会小倉記念病院（福岡）、岩本内科医院（福岡）、独立行政法人労働者健康安全機構九州労災病院（福岡）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 23 | 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
| 2021 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2021 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049483
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| Registered date | File name |
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