Status:

COMPLETED

Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial

Lead Sponsor:

The Second Hospital of Anhui Medical University

Collaborating Sponsors:

The First Affiliated Hospital of Anhui Medical University

Conditions:

Hepatobiliary Disease

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic resection.

Detailed Description

Background: Blood loss and the need for blood transfusions during the liver transection have shown to be correlated with higher morbidity and mortality rates and with worsen prognosis. Various devices...

Eligibility Criteria

Inclusion

  • Both male and female, aged 18 or older
  • Patients scheduled to undergo hepatic resection for some benign or malignant hepatobiliary disease
  • Child-Pugh class A or B liver function
  • BiClamp forceps hepatectomy and clamp-crushing feasible based on preoperative imaging
  • No tumor invasion the main vein, hepatic artery and vein and major inferior vena cava
  • No extrahepatic metastasis
  • Voluntary participation in the study, and informed consent.

Exclusion

  • Age \<18 years or\> 65 years , pregnant or lactating women
  • Preoperative liver function evaluation: Child-Pugh C grade
  • Laparoscopic hepatectomy
  • Extrahepatic metastasis
  • Tumor invasion the main vein, hepatic artery and vein and major inferior vena cava
  • The patient refused to sign the informed consent form

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2016

Estimated Enrollment :

105 Patients enrolled

Trial Details

Trial ID

NCT02197481

Start Date

September 1 2014

End Date

May 1 2016

Last Update

December 14 2017

Active Locations (1)

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the Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230022