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A Clinical Trial of the Vessel Sealing System (LigaSure) in Azygoportal Disconnection and Splenectomy in Patients With Portal Hypertension

NCT ID: NCT00965744

Last Updated: 2009-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-12-31

Brief Summary

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The aim of this trial was to verify the efficiency of a new surgical device (the LigaSure vessels sealing system) in esophagogastric decongestion and splenectomy in patients with portal hypertension.

Detailed Description

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Bleeding from esophageal and gastric cardia varices is the major life threatening complication in patients with portal hypertension. Patients with portal hypertension have a mortality rate of 30%-50% at the first episode of esophagogastric variceal rupture. The associated 1-year mortality rate is reported to be 75%. The ideal treatment for gastric varices should effectively control bleeding and improve the liver function to optimum levels. Although endoscopic treatments have showed great promise for esophageal varices, there is still controversy regarding the treatment of gastric varices. Hepatic encephalopathy remain a dominant problems after transjugular intrahepatic portosystemic shunt placement (TIPS) and surgical shunts. A meta-analysis has shown that the incidence of hepatic encephalopathy and mortality was increased significantly either in nonselective or selective shunt operations.

Esophagogastric decongestion and splenectomy with or without esophageal transaction were the fundamental operation performed in our department for patients with portal hypertension. Patients under the azygoportal devascularization methods revealed reduction of the encephalopathy as well as diminished rebleeding rates. The crucial point of the procedure is prevention of the brisk bleeding from the dilated vessels like enlarged azygoportal collaterals. Conventional hand-tied ligatures can become dislodged and represent a foreign body, and more important, it is tedious and time-consuming. The LigaSure vessel sealing system (Valleylab, Boulder, Colorado) is a bipolar electrosurgical device, sealing vessels up to 7 mm in diameter, by denaturing collagen and elastin within vessel wall and surrounding connective tissue. This device was tested, with excellent results, in different fields of surgery (gastrointestinal, hepatopancreatobiliary, urologic, gynecologic, laparoscopic, etc), as demonstrated by several recently published studies. Shamiyeh et al confirmed the reliability of LigaSure for the closure of the veins in laparoscopic azygoportal disconnection procedure on the portal hypertension porcine model in 2005, there was no intra- or post-operative bleeding and no conversion to open surgery, and when more than 2 mm far from the thermal energy source, no collateral damage of the solid tissue such as stomach could be detected.

Conditions

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Liver Cirrhosis

Keywords

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Ligasure vessel sealing system Azygoportal Disconnection Splenectomy Portal hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Vessel sealing system LigaSure (VS group)

Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.

Group Type EXPERIMENTAL

Vessel sealing system LigaSure

Intervention Type DEVICE

Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.

Conventional hand-tied method (CH group)

Patients in CH group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the conventional hand-tied method.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Vessel sealing system LigaSure

Patients in VS group undergoing esophagogastric decongestion (Azygoportal Disconnection) and splenectomy with or without esophageal transaction with the vessel sealing system LigaSure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with liver cirrhosis accompanied by portal hypertension and secondary hypersplenism due to hepatitis, alcoholic cirrhosis or schistosomiasis, who undergoing elective azygoportal disconnection and splenectomy

Exclusion Criteria

* Liver function as Child-Pugh C
* Hemoglobin \< 9 g/dL
* Ascites
* Abnormal coagulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shanghai Chang Zheng Hospital

Principal Investigators

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Qiang Wang, MD

Role: STUDY_CHAIR

Shanghai Chang Zheng Hospital

Jia Dong Gao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Surgery, Shanghai Chang Zheng Hospital

Wei Jun Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Surgery, Shanghai Chang Zheng Hospital

Hou Shan Yao, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Surgery, Shanghai Chang Zheng Hospital

Zhi Qian Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of General Surgery, Shanghai Chang Zheng Hospital

Locations

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Department of General Surgery, Shanghai Chang Zheng Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SCZH-0908-016

Identifier Type: -

Identifier Source: org_study_id