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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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.


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´╝Ť

2. with any preoperative adjuvant therapy.

3. with intrahepatic or extrahepatic malignancies;

4. cirrhosis with Child-Pugh class C

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

2010

Safety Issue:

No

Principal Investigator

Shen feng, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

Authority:

China: Ministry of Health

Study ID:

EHBH-RCT-2008-008

NCT ID:

NCT00851968

Start Date:

December 2008

Completion Date:

December 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • hepatectomy
  • Selective HepaticVascular Clamping
  • Carcinoma
  • Carcinoma, Hepatocellular

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