UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016956 |
|---|---|
| Receipt number | R000019680 |
| Scientific Title | Study of intraoperative navigation system in liver surgery |
| Date of disclosure of the study information | 2015/03/30 |
| Last modified on | 2017/03/29 11:42:37 |
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Basic information
Public title
Study of intraoperative navigation system in liver surgery
Acronym
Study of intraoperative navigation system in liver surgery
Scientific Title
Study of intraoperative navigation system in liver surgery
Scientific Title:Acronym
Study of intraoperative navigation system in liver surgery
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Liver metastasis, Hilar cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery | Radiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To validate the efficacy of intraoperative navigation system using Real-time Virtual Sonography in liver surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Error of resection line on the liver surface indicated by the navigation system
Key secondary outcomes
Weight of specimen
Surgical margin
Number of resected tumors
Time required for liver resection
Time required for registration
Time for use of the navigation system
Surgical time
Amount of blood loss
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Three-dimensional simulation of liver resection is performed with simulation software (OVA, Hitachi Medico; SYNAPSE VINCENT, FUJIFILM) utilizing the data of preoperative enhanced computed tomography (CT). The result of the simulation is transferred to a workstation.
The workstation is carried into the operation room and connected to an ultrasound scanner (Ascendus, Hitachi Aloka Medical) and a tracking device (trakSTAR, Ascension). An electromagnetic transmitter is set on the side of surgical bed. With the system, intraoperative ultrasound image and preoperative CT image on which simulation image is overlaid are displayed side-by-side on a television monitor.
After laparotomy, registration of the navigation system is performed by comparing the images of intraoperative ultrasound and preoperative CT. The resection line indicated by preoperative simulation is marked on the liver surface. The real resection line on the liver surface can be obtained by staining the tumor-baring area with blue dye (indigo carmine), or by dividing both portal vein and hepatic artery of the area. The discrepancy of those resection lines is measured.
In order to check the resection plane, the navigation image is referred during liver resection. After extirpating the liver specimen, its weight and surgical margin are measured. Resected tumor number, time required for resection, total surgical time and amount of blood loss are recorded after the operation.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Between 20 to 85 years of age
(2)Preoperative enhanced CT and three-dimensional simulation can be performed
(3)Liver neoplasm (hepatocellular carcinoma, intrahepatic cholangiocarcinoma, liver metastasis, hilar cholangiocarcinoma)
(4)Anatomic liver resection is scheduled
(5)Performance status 0 or 1
(6)Sufficient bone-marrow function for safe liver resection
(7)Sufficient liver function for safe liver resection
Key exclusion criteria
(1)Concomitant resection of other organ
(2)Major venous reconstruction
(3)Patient with pacemaker
(4)Severe renal dysfunction
(5)Severe tendency to bleed
(6)Patient with decreased judgment due to dementia or psychiatric disorder
(7)Patient who is regarded to be unsuitable for the study by the doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shouichi Satou |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
Address
1981, Kamoda, Kawagoe, Saitama, Japan
TEL
+81-49-228-3614
satous-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shouichi Satou |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Hepato-Biliary-Pancreatic Surgery
Zip code
Address
1981, Kamoda, Kawagoe, Saitama, Japan
TEL
+81-49-228-3614
Homepage URL
satous-tky@umin.ac.jp
Sponsor or person
Institute
Department of Hepato-Biliary-Pancreatic Surgery, Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Hitachi Aloka Medical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | 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
| 2015 | Year | 03 | Month | 28 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019680
