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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016956
Receipt No. 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

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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
Email 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
Email satous-tky@umin.ac.jp

Sponsor
Institute Department of Hepato-Biliary-Pancreatic Surgery, Saitama Medical Center, Saitama Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019680

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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