Clinical trial NCT00851968: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatectomy
Selective HepaticVascular Clamping
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-02-26
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: 2010
Secondary outcomes:
measure: 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
timeFrame: 2010
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University
name: Shen feng, MD
role: STUDY_CHAIR
References: