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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014198
Receipt No. R000016531
Scientific Title Observational research: To evaluate the feasibility of ultrasound-guided segmental Glissonian pedicle radiofrequency ablation (RFA) prior to liver resection in HCC patients.
Date of disclosure of the study information 2014/06/06
Last modified on 2014/06/06

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Basic information
Public title Observational research: To evaluate the feasibility of ultrasound-guided segmental Glissonian pedicle radiofrequency ablation (RFA) prior to liver resection in HCC patients.
Acronym Ultrasound-guided RFA in liver segmentectomy
Scientific Title Observational research: To evaluate the feasibility of ultrasound-guided segmental Glissonian pedicle radiofrequency ablation (RFA) prior to liver resection in HCC patients.
Scientific Title:Acronym Ultrasound-guided RFA in liver segmentectomy
Region
Asia(except Japan)

Condition
Condition Anatomic Liver Resection/RFA
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to further evaluate the clinical feasibility and safety of this new technique for resection of hepatic segments or subsegments – from segment 2 through segment 8.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The technique of ultrasound guided RFA ablation of the segmental glissonian pedicle is expedient, safe and effective, and is suitable for the resection of any hepatic segments and subsegments from segment 2 to segment 8.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We include adults
1. Aged 18 or over
2. Who are diagnosed as HCC with tumors ranging from 2 to 5cm located in any hepatic segment or in intersectional place, but no one complicated with portal or hepatic venous cancerous thrombosis which must demand an extensive hepatectomy
3. Liver function was reclassified as Child-Pugh A
Key exclusion criteria We will exclude subjects who:
1. Impossible to tolerate the operation because of respiratory or circulatory system diseases
2. with any thrombotic complications that necessitate extensive hepatectomy
3. Liver function in all cases was Child-Pugh B or C.
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jia-Hong Dong
Organization Chinese PLA General Hospital
Division name Hospital & Institute of Hepatobiliary Surgery
Zip code
Address No. 28, Fuxing Road/Street, Beijing, China
TEL 86-10-66938030
Email dongjh301@163.com

Public contact
Name of contact person
1st name
Middle name
Last name Jia-Hong Dong
Organization Chinese PLA General Hospital
Division name Hospital & Institute of Hepatobiliary Surgery
Zip code
Address No. 28, Fuxing Road/Street, Beijing, China
TEL 86-10-66938030
Homepage URL
Email dongjh301@163.com

Sponsor
Institute Chinese PLA General Hospital
Institute
Department

Funding Source
Organization budget
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 06 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 The procedure was feasible in all selected patients, with no mortality, morbidity, nor blood transfusions.
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 Completed
Date of protocol fixation
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 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 We measured the effect of demarcation, RFA duration, numbers and diameters of ablated vessels, and procedure duration.
We studied the morbidity cases, mortality cases, amount of blood loss, rate of blood transfusions, and serum levels of total bilirubin, aspartate aminotransferase, alanine aminotransferase on 1st, 3rd, 5th, and 7th postoperative day, three-phase contrast-enhanced CT scan/MRI on 7th postoperative day

Management information
Registered date
2014 Year 06 Month 06 Day
Last modified on
2014 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016531

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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