UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014198 |
|---|---|
| Receipt number | 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 20:41:42 |
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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
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
dongjh301@163.com
Sponsor or person
Institute
Chinese PLA General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016531
