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Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy

Pringle's Maneuver Versus Selective Hepatic Vascular Exclusion in Hepatectomy About Recurrence and Survival :A Prospective Randomized Trial

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00820339
Acronym
SHVE
Enrollment
132
Registered
2009-01-12
Start date
2009-01-31
Completion date
2012-11-30
Last updated
2016-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, hepatic vein, Surgical resection, occlusion, time to recurrence, overall survival

Brief summary

To confirm that SHVE is a safe and effective procedure and it can prevent bleeding of the hepatic vein. To evaluate the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE.To evaluate that SHVE can improve survival in HCC patients or not.

Detailed description

Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad still shows a rising trend. In recent decade, the overall survival rate of the disease has entered a platform stage with little advance despite diversified methods of treatment. The prognosis of HCC is not so satisfying. Intraoperative bleeding remains a major concern during liver resection. Blood loss usually occurs during parenchymal transection and reperfusion after Pringle's maneuver. The amount of blood loss and the need for blood transfusion have a detrimental effect on the short- and long-term prognosis. Portal triad clamping is sufficient in most situations to control bleeding during hepatectomy. However, it does not prevent backflow bleeding from hepatic veins, which may become troublesome or even hazardous. This is particularly true in tumors that are large or that have invaded into the branches of the major hepatic veins. SHVE completely isolates the liver from the systemic circulation with the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE. The purpose of the study is to assess the risk factors for the recurrence and metastasis in HCC patients undergoing hepatectomy by SHVE and to evaluate that SHVE can improve survival in HCC patients or not.

Interventions

Inflow occlusion with extraparenchymal control of major hepatic veins results in total liver isolation from the systemic circulation but without interruption of caval flow.

Hepatic pedical 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.

Sponsors

Eastern Hepatobiliary Surgery Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Corresponding to diagnostic standards of HCC. * Patients of liver tumors underwent resection with occlusion of more than one main hepatic veins. * liver function in the Child-Pugh classification A or B. * Age between 18\ 70 years. * Haven't taken any current treatment. * Understanding and being willing to sigh the informed consent form.

Exclusion criteria

* cannot be follow-up * severe liver, renal, or brain dysfunction * with tumor thrombi in the main trunk of portal vein * with tumor thrombi in the hepatic vein * with extrahepatic metastasis

Design outcomes

Primary

MeasureTime frame
Overall survival1,2,or 3 years

Secondary

MeasureTime frame
Blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications1,2,or 3 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026