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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043358
Receipt No. 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

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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
Email 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
Email atak51ks331007@gmail.com

Sponsor
Institute Japan Seafarers Relief Association Moji Ekisaikai Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049483

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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