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NCT Number: NCT02197481

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

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.

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Key information

Conditions

Hepatobiliary Disease Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

the Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

About this study

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:

  • 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.
  • Statistical method: groups t-test, univariate/multivariate analysis, logistic regression analysis, mixed linear regression and Cox survival analysis were used.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Clamp-Crushing technique

Procedure

Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps

BiClamp forceps

Device

liver transection during hepatectomy by BiClamp forceps

Primary outcomes

  1. The Total Blood Loss

    Time frame: an expected average of 80 minutes

    Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection

Secondary outcomes

  1. Liver Transection Time

    Time frame: an expected average of 40 minutes

    liver transection time was calculated from the beginning to the end of the liver resection

  2. Mortality

    Time frame: 90 days

    Operative mortality was defined as any death resulting from a complication during surgery

  3. Morbidity

    Time frame: 90 days

  4. Biliary Leakage

    Time frame: 90 days

    Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems

  5. Duration of Postoperative Hospital Stay

    Time frame: an expected average of 12 days

    Time from day of operation to day of discharge

  6. Number of Participants Requiring a Blood Transfusion

    Time frame: 2 days

    Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively

  7. Total Bilirubin

    Time frame: 3 postoperative day

    serum total bilirubin on 3 postoperative day (umol/L)

Sponsors and collaborators

Lead sponsor

The Second Hospital of Anhui Medical University

Other

Collaborators

  • The First Affiliated Hospital of Anhui Medical University

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2014
Registry last updated
Dec 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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