Pringle's Maneuver Versus Selective Hepatic Vascular Excl... | NCT00820339

Studies
Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy

NCT00820339

Sponsor

Eastern Hepatobiliary Surgery Hospital

Status

Completed

Last Update Posted

Apr 1, 2016Estimated

Enrollment

132Actual

Phase

Phase 2Phase 3

Conditions

Hepatocellular Carcinoma

Interventions

Selective Hepatic Vascular Exclusion
Pringle's Maneuver

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

Mar 2016

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 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jan 9, 2009

First Submission Date that Met QC Criteria

Jan 9, 2009

First Posted Date

Jan 12, 2009Estimated

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

Mar 30, 2016

Last Update Posted Date

Apr 1, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery HospitalPrincipal Investigator

Lead Sponsor

Eastern Hepatobiliary Surgery HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not.

Detailed Description

Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying.

Intraoperative bleeding remains a major concern during liver resection. Blood loss usually occurs during parenchymal transection and reperfusion after Pringle's maneuver. The amount of blood loss and the need for blood transfusion have a detrimental effect on the short- and long-term prognosis.

Portal triad clamping is sufficient in most situations to control bleeding during hepatectomy. However, it does not prevent backflow bleeding from hepatic veins, which may become troublesome or even hazardous. This is particularly true in tumors that are large or that have invaded into the branches of the major hepatic veins.

SHVE completely isolates the liver from the systemic circulation with the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.

The purpose of the study is to assess the risk factors for the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE and to evaluate that SHVE can improve survival in HCC patients or not.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Selective Hepatic Vascular Exclusion	Active Comparator	Patients with HCC received Selective Hepatic Vascular Exclusion in hepatectomy.	Procedure: Selective Hepatic Vascular Exclusion
Pringle's Maneuver	Experimental	Patients with HCC received Pringle's Maneuver in hepatectomy.	Procedure: Pringle's Maneuver

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Selective Hepatic Vascular Exclusion	Procedure	Inflow occlusion with extraparenchymal control of major hepatic veins results in total liver isolation from the systemic circulation but without interruption of caval flow.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		1,2,or 3 years

Secondary Outcomes

Measure	Description	Time Frame
Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications		1,2,or 3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Corresponding to diagnostic standards of HCC.
Patients of liver tumors underwent resection with occlusion of more than one main hepatic veins.
liver function in the Child-Pugh classification A or B.
Age between 18~70 years.
Haven't taken any current treatment.
Understanding and being willing to sigh the informed consent form.

Exclusion Criteria:

cannot be follow-up
severe liver, renal, or brain dysfunction
with tumor thrombi in the main trunk of portal vein
with tumor thrombi in the hepatic vein
with extrahepatic metastasis

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Feng Shen, M.D.	Eastern Hepatobiliary Surgery Hospital, Second Military Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastern hepatobilliary surgery hospital		Shanghai	Shanghai Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D001733	Bites and Stings

Ancestor Terms

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

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Browse Branches

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