The Short-term Efficacy of Novel NTDP-RFA in the Treatment of Small HCC With Cirrhosis.
1 other identifier
observational
100
1 country
2
Brief Summary
To evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
August 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedAugust 14, 2020
August 1, 2020
5.5 years
July 31, 2020
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of local tumor progression (LTP)
LTP was defined as the appearance of new tumor foci near 2 cm at the ablative margin after the local eradication of all tumor cells with RFA
two-years local tumor progression-free survival
Secondary Outcomes (1)
Tumor-free survival
two-years tumor-free survival
Eligibility Criteria
Patients with primary hepatocellular carcinoma with cirrhosis
You may qualify if:
- Primary hepatocellular carcinoma with a background of cirrhosis
- Single shot with diameter ≤ 3cm
- The tumor did not invade portal vein, hepatic vein trunk and secondary branches
- Child Pugh A/B
- ICG-R15 ≤ 30%
- years old
- The follow-up time reached 2 years
You may not qualify if:
- The follow-up time is less than 2 years
- multiple lesions or diameter \> 3cm
- Previous history of upper gastrointestinal bleeding or severe hypersplenism
- Patients with extrahepatic or lymph node metastasis
- Wish to receive liver transplantation and hepatectomy
- The lesion is adjacent to the gallbladder, important blood vessels and bile ducts in the hilum of the liver and important organs around
- severe bleeding tendency, platelet count \< 50 × 10\^9/L, or prothrombin time prolonged \> 3s
- Other anti-tumor therapies were accepted before surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
Institute of hepatobiliary surgery,Southwest Hospital
Chongqing, Chongqing Municipality, 400038, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kuansheng Ma, Ph.D
Institute of hepatobiliary surgery,Southwest Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
July 31, 2020
First Posted
August 14, 2020
Study Start
January 1, 2017
Primary Completion
July 1, 2022
Study Completion
August 31, 2022
Last Updated
August 14, 2020
Record last verified: 2020-08