Effect of Tumor Micronecrosis on Postoperative Transcathe... | NCT05352204

Studies
Effect of Tumor Micronecrosis on Postoperative Transcatheter Arterial Chemoembolization in Patients With Hepatocellular Carcinomas

NCT05352204

Sponsor

Zhejiang University

Status

Completed

Last Update Posted

Feb 14, 2023Actual

Enrollment

900Actual

Phase

Not provided

Conditions

Carcinoma, Hepatocellular

Interventions

transcatheter arterial chemoembolization

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2020Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Apr 14, 2022Actual

First Submitted Date

Apr 22, 2022

First Submission Date that Met QC Criteria

Apr 22, 2022

First Posted Date

Apr 28, 2022Actual

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

Feb 11, 2023

Last Update Posted Date

Feb 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Micronecrosis is a novel pathological feature of hepatocellular carcinoma (HCC). This study was aimed at evaluating the effect of tumor micronecrosis on postoperative transcatheter arterial chemoembolization (TACE) in patients with hepatocellular carcinomas, and further exploring the value of micronecrosis for guiding TACE in HCC management.

Detailed Description

Not provided

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

900Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
micronecrosis(+) group			Procedure: transcatheter arterial chemoembolization
micronecrosis(-) group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
transcatheter arterial chemoembolization	Procedure	transcatheter arterial chemoembolization after liver resection	micronecrosis(+) group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	the number of months from the date of surgery to the date of the last follow-up visit or time of death.	after liver resection until June 1, 2020

Secondary Outcomes

Measure	Description	Time Frame
disease-free survival	the number of months from the date of surgery to the date of first confirmable recurrence or death	after liver resection until June 1, 2020

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) pathologically confirmed HCC (2) achievement of R0 resection.

Exclusion Criteria:

(1) simultaneous presence of other tumors ; (2) receipt of preoperative anti-tumoral treatments; (3) concurrent treatment with other antitumoral therapies in combination with TACE; (4) tumor necrosis that could be observed by gross examination; (5) a lack of necessary preoperative laboratory test results.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

From June 2014 to April 2018, HCC patients who underwent liver resection in our center were retrospectively reviewed.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Affiliated Hospital, School of Medicine, Zhejiang University		Hangzhou	Zhejiang	310009	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

Browse Leaves

Not provided

Browse Branches

Not provided