UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of intraoperative navigation system in liver surgery
Title of the study (Brief title)	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	Shouichi Satou
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Hepato-Biliary-Pancreatic Surgery
Address	1981, Kamoda, Kawagoe, Saitama, Japan
TEL	+81-49-228-3614
Email	satous-tky@umin.ac.jp

Public contact
Name of contact person	Shouichi Satou
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Hepato-Biliary-Pancreatic Surgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019680