Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment
Recruitment status was Recruiting
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Purpose
Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.This study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with hemihepatic vascular clamping and Pringle maneuver.
| Condition | Intervention |
|---|---|
|
Hepatocellular Carcinoma |
Procedure: Total hemihepatic vascular exclusion Procedure: Hemihepatic vascular Clamping Procedure: Pringle's Maneuver |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Controlled Trial of Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment |
- Overall survival and disease free survival [ Time Frame: 1,2,or 3 years ] [ Designated as safety issue: No ]
- Bleeding and blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications [ Time Frame: 1,2,or 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Total Hemihepatic Vascular Exclusion
Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.
|
Procedure: Total hemihepatic vascular exclusion
A long vascular clamp is inserted along the midline of the anterior surface of the vena cava,proceed cranially up to the space between the right and the middle hepatic vein trunks. Two tapes are seized with the clamp passing between the anterior surface of the IVC and the liver parenchyma.One tape is use to pass around the hepatic parenchyma for occlusion of the bleeding from the remnant liver;the other is used to loop the right (or left )hepatic vein trunk and short hepatic vein,as well as inferior right hepatic vein,if present. Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection.Thus total hemihepatic vascular exclusion is achieved.
Other Name: THHVE group
|
|
Experimental: Hemihepatic vascular Clamping
Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.
|
Procedure: Hemihepatic vascular Clamping
Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection. Selective clamping can be achieved after carefully dissecting the right from the left hilar branches or after inserting a clamp between the right and left hilar branches without prior hilar dissection and looping the right or left portal structures with a tape.
Other Name: Hemihepatic vascular Clamping group
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Experimental: Pringle's Maneuver
Patients with HCC received Pringle's Maneuver in hepatectomy.
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Procedure: Pringle's Maneuver
Hepatic pedicle clamping is performed by encircling the hepatoduodenal ligament with a tape and then applying a tourniquet or a vascular clamp until the pulse in the hepatic artery disappears distally.
Other Name: Pringle's Maneuver group
|
Detailed Description:
The amount of blood loss and blood transfusion in Hepatectomy have a detrimental effect on the prognosis for Hepatocellular carcinoma(HCC).Intraoperative bleeding remains a major concern during liver resection. The most often used hepatic vascular control methods at present are hepatic pedicle occlusion(Pringle maneuver), hemihepatic vascular clamping,segmental vascular clamping and total hepatic vascular exclusion (THVE).However,all these methods have shortcomings. Pringle maneuver cannot prevent bleeding from hepatic veins and leads to ischemia-reperfusion injury of the liver; Hemihepatic vascular clamping cannot prevent bleeding from hepatic veins as well, and from the remnant (nonoccluded) liver. THVE is a technically demanding technique that requires surgical and anesthetic expertise and may lead to hemodynamic intolerance as well as increased morbidity and hospital stay. Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.
The purpose of this study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with other occlusion methods.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
5Inclusion Criteria:
- Understanding and being willing to sigh the informed consent form.
- Aged 18-75years.
- Corresponding to diagnostic standards of HCC, without any adjuvant therapy,tumor or multiple tumors located in right or left liver lobe.
- The function of heart, lung ,renal is well,without any surgery contraindication.
- KPS score≥60分
- Liver function in the Child-Pugh classification is A or B.
- Tumor AJCC stage isⅠorⅡ.
Exclusion Criteria:
- cannot be follow-up
- liver function in the Child-Pugh classification is C.
- with tumor thrombus in the hepatic vein or main trunk of portal vein
- with extrahepatic metastasis
Contacts and Locations| Contact: chengjun Sui, M.D | 0086-21-25075395 | suichengjun1978@hotmail.com |
| Contact: jiamei Yang, M.D | 0086-21-25070808 | jiameiyang@gmail.com |
| China, Shanghai | |
| Eastern hepatobilliary surgery hospital | Recruiting |
| Shanghai, Shanghai, China | |
| Contact: chengjun Sui, M.D 0086-21-25075395 suichengjun1978@hotmail.com | |
| Contact: jiamei Yang, M.D 0086-21-25070808 jiemeiyang@gmail.com | |
| Study Chair: | Feng Shen, M.D | Eastern Hepatobiliary Surgery Hospital, Second Military Medical University |
More Information
No publications provided
| Responsible Party: | Jiamei Yang, The Department of Special Treatment , Eastern Hepatobiliary Surgery Hospital |
| ClinicalTrials.gov Identifier: | NCT00827047 History of Changes |
| Other Study ID Numbers: | EHBH-RCT-2008-012 |
| Study First Received: | January 21, 2009 |
| Last Updated: | January 21, 2009 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Eastern Hepatobiliary Surgery Hospital:
|
hepatocellular carcinoma Surgical resection total hemihepatic vascular exclusion |
occlusion bleeding overall survival |
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 16, 2013