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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
320

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
overall survival
Time Frame: 2010
2010

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eastern Hepatobiliary Surgery Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 24, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EHBH-RCT-2008-008

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