The Short-term Efficacy of Novel NTDP-RFA in the Treatmen... | NCT04513119

Studies
The Short-term Efficacy of Novel NTDP-RFA in the Treatment of Small HCC With Cirrhosis.

NCT04513119

Sponsor

Southwest Hospital, China

Status

Unknown status

Last Update Posted

Aug 14, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hepatocellular Carcinoma Stage I
Radiofrequency Ablation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jul 1, 2022Estimated

Completion Date

Aug 31, 2022Estimated

First Submitted Date

Jul 31, 2020

First Submission Date that Met QC Criteria

Aug 11, 2020

First Posted Date

Aug 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 11, 2020

Last Update Posted Date

Aug 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Liver cancer is the fourth leading cause of cancer-related deaths globally. Hepatocellular carcinoma (HCC) accounts for 70% to 85% of primary HCC and is the leading cause of death in patients with cirrhosis. We developed a novel no-touch combined directional perfusion radiofrequency ablation system.By inserting two or more electrodes around the tumor and activating them simultaneously.The hypertonic saline solution can be directed into the focal tissue from a lateral pore through a tube within the electrode to provide more uniform and thorough necrosis.The maximum ablation volume was increased while the loss of normal tissue in the non-injection direction was reduced, thus reducing the incidence of postoperative complications. Therefore, the purpose of this study was to evaluate the short-term efficacy of novel no-touch combined directional perfusion radiofrequency ablation in the treatment of small hepatocellular carcinoma with cirrhosis.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Tumor-free survival	The tumor did not recur after treatment.	two-years tumor-free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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%
18-70 years old
The follow-up time reached 2 years

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with primary hepatocellular carcinoma with cirrhosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kai Feng, M.D	Contact	+86-23-13228683383		fengkai7688@hotmail.com

Overall Officials

Name	Affiliation	Role
Kuansheng Ma, Ph.D	Institute of hepatobiliary surgery,Southwest Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of hepatobiliary surgery,Southwest Hospital	Enrolling by invitation	Chongqing	Chongqing Municipality	400038	China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

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