A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

March 30, 2016 updated by: ShenFeng, Eastern Hepatobiliary Surgery Hospital

A Prospective Randomized Controlled Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

Intraoperative bleeding remains a major concern during liver resection. Pringle maneuver is the most frequently used method to occlude inflow blood of the liver.However, experimental and clinical studies have shown than even short periods of clamping produce some degree of ischemia-reperfusion injury that can result in hepatocellular damage,this damage being especially important in patients with abnormal liver parenchyma such as steatosis and cirrhosis. The aim of this study was to evaluate whether the use of selective vascular clamping should be generalized to HCC patients and help to reduce the ischemia-reperfusion injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From recent animal studies, it can be easily concluded that I/R injury of the liver may be a significant factor, which can promote the primary liver tumor recurrence and metastasis. If it is a truth in human, there must be a big challenge to the Pringle maneuver which was adopted routinely in hepatectomy in the past years. Pringle maneuver during hepatic resection may do harm to the liver function, make the tumor cell more aggressive and tend to recurrence. It is suggested that further strategies may be needed for the prevention and treatment of I/R injury ,early and late recurrences.Selective hepatic vascular clamping (SVC)such as hemihepatic vascular occlusion have been used to minimize ischemic injury during liver surgery, especially in patients with abnormal liver parenchyma. However,these procedure used is likely to depend on the surgeon's training or preference rather than on objective data, there is not any further reported data or RCT studies conducted about the postoperative outcome ,especially liver function.To address these issues,we designed a prospective randomized controlled trial comparing the complete hepatic vascular clamping (Pringle maneuver) and selective hepatic vascular clamping ( portal vein or hemi-hepatic occlusion) in patients undergoing hepatectomy. The main objective was to compare the liver I/R injury of two procedures to the postoperative liver function. The secondary objective was to evaluate the feasibility, safety, efficacy, amount of hemorrhage,postoperative complications ,disease-free and overall survival rate of the 2 procedures.

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200438
        • Eastern Hepatobiliary Surgery Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. with a clinical diagnosis of primary liver cancer, without any adjuvant therapy;
  2. age:18-70years;
  3. suitable for partial hepatectomy without other malignancies;
  4. compensated cirrhosis with Child-Pugh class A, or B.

Exclusion criteria:

  1. reject to attend；
  2. with any preoperative adjuvant therapy.
  3. with intrahepatic or extrahepatic malignancies;
  4. cirrhosis with Child-Pugh class C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pringle's Maneuver
Patients with HCC received Pringle's Maneuver in hepatectomy.
Procedure: Pringle's Maneuver
The entire hilar pedicle was encircled with a rubber tape to perform a Pringle maneuver with a tourniquet.
Other Names:
  • Pringle's Maneuver group
Experimental: Hemihepatic vascular Clamping
Patients with HCC received Hemihepatic vascular Clamping in hepatectomy
Procedure: Hemihepatic vascular Clamping
The portal vein,hepatic artery ,and biliary duct were dissected in the hilum by opening the peritoneal fascia. Either the right or left portal pedicle was isolated and encircled with a tourniquet or clamped with Shatinsky clamp. Separate clamping of accessory left hepatic artery was performed when present in controlling the left hemihepatic portal traid.
Other Names:
  • Hemihepatic vascular Clamping group
Experimental: portal vein occlusion
Patients with HCC received portal vein occlusion in hepatectomy
Procedure: Portal vein occlusion
The proper hepatic artery was dissected first from the duodenohepatic ligament, portal pedicle was blocked with a rubber encircled through the posterior wall of proper hepatic artery and the bottom of duodenohepatic ligament.When aberrant hepatic arteries emerging from the superior mesenteric artery are found in duodenohepatic ligament ,they should be dissected and kept unobstructed.
Other Names:
  • Portal vein occlusion group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 2010
2010

Secondary Outcome Measures

Outcome Measure
Time Frame
serum alanine aminotransferase (ALT), bilirubin, prothrombin time, serum albumin and pre-albumin on postoperative 1, 3, 7 day, resection rate, procedure-related complications and hospital mortality,expression of HIF and P-, E-, and L-selectin
Time Frame: 2010
2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Hepatobiliary Surgery Hospital

Investigators

  • Study Chair: Shen feng, MD, Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

February 25, 2009

First Posted (Estimate)

February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

April 1, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHBH-RCT-2008-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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