NCT02197481

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

BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: The Second Hospital of Anhui Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 of liver parenchymal transection have been developed with a view to reducing the intraoperative blood loss. However, to the present there is no randomized controlled trial evaluating the technique of BiClamp forceps during the liver transection. The goal of the present study was to evaluate the safety and effectiveness of BiClamp forceps transection in comparison to the clamp crushing technique in patients offered liver resection. Intervention: One hundred patients with hepatobiliary disease need undergo hepatectomy at Anhui medical university were selected and divided into BiClamp forceps hepatectomy group and clamp-crushing hepatectomy group, each group contains 50 cases. Results: 1. Clinical data include: blood loss during liver transection, total blood loss, blood transfusion, hospital stay, morbidity, mortality, biliary leakage, postoperative liver function, liver transection time, operation time, resection margins, need for portal trial clamping. 2. Statistical method: groups t-test, univariate/multivariate analysis, logistic regression analysis, mixed linear regression and Cox survival analysis were used.

Conditions

• Hepatobiliary Disease

Interventions

Type	Name	Description
PROCEDURE	Clamp-Crushing technique	Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
DEVICE	BiClamp forceps	liver transection during hepatectomy by BiClamp forceps

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2014-07-22
• Last updated: 2017-12-14
• Results posted: 2017-12-14

Locations

1 site across 1 country: China