Management of Spontaneous Ruptured Hepatocellular Carcinoma | NCT03516890

Studies
Management of Spontaneous Ruptured Hepatocellular Carcinoma

NCT03516890

Sponsor

Huazhong University of Science and Technology

Status

Completed

Last Update Posted

May 4, 2018Actual

Enrollment

216Actual

Phase

Not provided

Conditions

Rupture, Spontaneous
Rupture Liver
Hepatocellular Carcinoma

Interventions

Partial hepatectomy

Countries

Not provided

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

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

Jan 1, 2005Actual

Primary Completion Date

Jun 1, 2015Actual

Completion Date

Dec 1, 2017Actual

First Submitted Date

Apr 4, 2018

First Submission Date that Met QC Criteria

May 3, 2018

First Posted Date

May 4, 2018Actual

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

May 3, 2018

Last Update Posted Date

May 4, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaoping Chen, Professor, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 investigate the best treatment for hepatocellular carcinoma rupture

Detailed Description

To investigate the best treatment for hepatocellular carcinoma rupture, transcatheter arterial embolization or partial hepatectomy. Furthermore, to discuss the choice of emergency or staged hepatectomy.

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

216Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Partial hepatectomy	Procedure	Partial hepatectomy was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival of all patients	Overall survival difference between the partial hepatectomy group and the non-surgical group	5 years

Secondary Outcomes

Measure	Description	Time Frame
Postoperative peritoneal dissemination	Postoperative peritoneal dissemination diagnosed by imaging examination	5 years
Recurrence-free survival of all patients	Recurrence-free survival difference between the partial hepatectomy group and the non-surgical group

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Being diagnosed as hepatocellular carcinoma with tumor rupture; with complete data and without loss of follow-up

Exclusion Criteria:

Without complete data; with loss of follow-up; not hepatocellular carcinoma based on pathological diagnosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

76 Years

Standard Ages

ChildAdultOlder Adult

Study Population

From January 2005 to June 2015, all patients complied with the criteria mentioned above who received partial hepatectomy or non-surgical at our center were included in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xiao-ping Chen, PHD	Huazhong University of Science and Technology	Study Chair

Locations

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	May 3, 2018	May 3, 2018	SAP_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D012422	Rupture, Spontaneous
D006528	Carcinoma, Hepatocellular
D004630	Emergencies

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D000230	Adenocarcinoma
D002277	Carcinoma

Browse Leaves

Not provided

Browse Branches

Not provided