A Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention |
|---|---|
|
Hepatocellular Carcinoma |
Procedure: Pringle's Maneuver Procedure: Hemihepatic vascular Clamping Procedure: Portal vein occlusion |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Controlled Trial of Complete Versus Selective HepaticVascular Clamping in Hepatectomy |
- overall survival [ Time Frame: 2010 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 320 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| China, Shanghai | |
| Eastern Hepatobiliary Surgery Hospital | |
| Shanghai, Shanghai, China, 200438 | |
| Study Chair: | Shen feng, MD | Eastern Hepatobiliary Surgery Hospital Affiliated to Second Military Medical University |
More Information
No publications provided
| Responsible Party: | Li Aijun, Eastern Hepatobiliary Surgery Hospital |
| ClinicalTrials.gov Identifier: | NCT00851968 History of Changes |
| Other Study ID Numbers: | EHBH-RCT-2008-008 |
| Study First Received: | February 24, 2009 |
| Last Updated: | February 25, 2009 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Eastern Hepatobiliary Surgery Hospital:
|
hepatectomy Selective HepaticVascular Clamping |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 23, 2013