Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy

NCT00820339 | Completed Phase 2 DMC

• 1 other identifier: EHBH-RCT-2008-002
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma; hepatic vein; Surgical resection; occlusion; time to recurrence; overall survival

Outcome Measures

Primary Outcomes (1)

• Overall survival

  1,2,or 3 years

Secondary Outcomes (1)

• Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications

  1,2,or 3 years

Study Arms (2)

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

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.

Also known as: SHVE group

Selective Hepatic Vascular Exclusion

Pringle's Maneuver PROCEDURE

Hepatic pedical clamping is performed by encircling the hepatoduodenal ligament with a tape and then applying a tourniquet or a vascular clamp until the pulse in the hepatic artery disappears distally.

Also known as: Pringle's Maneuver group

Pringle's Maneuver

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern hepatobilliary surgery hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Bites and Stings

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Feng Shen, M.D.

  Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president of the Eastern Hepatobiliary Surgery Hospotal

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 12, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: November 1, 2012
• Last Updated: April 1, 2016

Record last verified: 2016-03

Locations

CN (1)