A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

NCT ID: NCT00851968

Last Updated: 2016-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2010-12-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pringle's Maneuver

Patients with HCC received Pringle's Maneuver in hepatectomy.

Group Type: ACTIVE_COMPARATOR

Pringle's Maneuver

Intervention Type: PROCEDURE

The entire hilar pedicle was encircled with a rubber tape to perform a Pringle maneuver with a tourniquet.

Hemihepatic vascular Clamping

Patients with HCC received Hemihepatic vascular Clamping in hepatectomy

Group Type: EXPERIMENTAL

Hemihepatic vascular Clamping

Intervention Type: PROCEDURE

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.

portal vein occlusion

Patients with HCC received portal vein occlusion in hepatectomy

Group Type: EXPERIMENTAL

Portal vein occlusion

Intervention Type: PROCEDURE

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.

Interventions

Pringle's Maneuver

The entire hilar pedicle was encircled with a rubber tape to perform a Pringle maneuver with a tourniquet.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Pringle's Maneuver group; Hemihepatic vascular Clamping group; Portal vein occlusion group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role: lead

Responsible Party

ShenFeng

vice president of the Eastern Hepatobiliary Surgery Hospotal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shen feng, MD

Role: STUDY_CHAIR

Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

Locations

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

EHBH-RCT-2008-008

Identifier Type: -

Identifier Source: org_study_id