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A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy

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ClinicalTrials.gov Identifier: NCT00851968
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : April 1, 2016
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Procedure: Pringle's Maneuver Procedure: Hemihepatic vascular Clamping Procedure: Portal vein occlusion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Controlled Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy
Study Start Date : December 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: Portal vein occlusion group




Primary Outcome Measures :
  1. overall survival [ Time Frame: 2010 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851968


Locations
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China, Shanghai
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China, 200438
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
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Study Chair: Shen feng, MD Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University

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Responsible Party: ShenFeng, vice president of the Eastern Hepatobiliary Surgery Hospotal, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT00851968    
Other Study ID Numbers: EHBH-RCT-2008-008
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: April 1, 2016
Last Verified: March 2016
Keywords provided by ShenFeng, Eastern Hepatobiliary Surgery Hospital:
hepatectomy
Selective HepaticVascular Clamping
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases