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A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pringle's Maneuver
Hemihepatic vascular Clamping
Portal vein occlusion
Sponsored by
Eastern Hepatobiliary Surgery Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring hepatectomy, Selective HepaticVascular Clamping

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eastern Hepatobiliary Surgery Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Pringle's Maneuver

Hemihepatic vascular Clamping

portal vein occlusion

Arm Description

Patients with HCC received Pringle's Maneuver in hepatectomy.

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy

Patients with HCC received portal vein occlusion in hepatectomy

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2009
Last Updated
March 30, 2016
Sponsor
Eastern Hepatobiliary Surgery Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00851968
Brief Title
A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy
Official Title
A Prospective Randomized Controlled Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Eastern Hepatobiliary Surgery Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
hepatectomy, Selective HepaticVascular Clamping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pringle's Maneuver
Arm Type
Active Comparator
Arm Description
Patients with HCC received Pringle's Maneuver in hepatectomy.
Arm Title
Hemihepatic vascular Clamping
Arm Type
Experimental
Arm Description
Patients with HCC received Hemihepatic vascular Clamping in hepatectomy
Arm Title
portal vein occlusion
Arm Type
Experimental
Arm Description
Patients with HCC received portal vein occlusion in hepatectomy
Intervention Type
Procedure
Intervention Name(s)
Pringle's Maneuver
Other Intervention Name(s)
Pringle's Maneuver group
Intervention Description
The entire hilar pedicle was encircled with a rubber tape to perform a Pringle maneuver with a tourniquet.
Intervention Type
Procedure
Intervention Name(s)
Hemihepatic vascular Clamping
Other Intervention Name(s)
Hemihepatic vascular Clamping group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Portal vein occlusion
Other Intervention Name(s)
Portal vein occlusion group
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
2010
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: with a clinical diagnosis of primary liver cancer, without any adjuvant therapy; age:18-70years; suitable for partial hepatectomy without other malignancies; compensated cirrhosis with Child-Pugh class A, or B. Exclusion criteria: reject to attend; with any preoperative adjuvant therapy. with intrahepatic or extrahepatic malignancies; cirrhosis with Child-Pugh class C
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen feng, MD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China

12. IPD Sharing Statement

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A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

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