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Phase 3 Completed N=86 Randomized Treatment

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

Hepatobiliary Disease
Source: ClinicalTrials.gov NCT02197481 ↗
Enrolled (actual)
86
Serious AEs
7.0%
Results posted
Dec 2017
Primary outcomePrimary: The Total Blood Loss — 376.73; 339.81 ml
◆ Published Evidence
Highly cited
572citations · ~25 / year
Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases.
Annals of surgery · 2003 · Open access · High-confidence link

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.

Linked Publications (4)

  • Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases.
    Annals of surgery · 2003 · 572 citations · Open access · High-confidence link
  • Techniques for liver parenchymal transection in liver resection.
    The Cochrane database of systematic reviews · 2009 · 113 citations · Open access · High-confidence link
  • Impact of the VIO system in hepatic resection for patients with hepatocellular carcinoma.
    Surgery today · 2012 · 41 citations · High-confidence link
  • BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial.
    Trials · 2015 · 7 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
The Total Blood Loss
376.73; 339.81
SECONDARY
Liver Transection Time
25.51; 26.21
SECONDARY
Mortality
0; 0
SECONDARY
Morbidity
13; 12
SECONDARY
Biliary Leakage
4; 2
SECONDARY
Duration of Postoperative Hospital Stay
8.65; 8.81
SECONDARY
Number of Participants Requiring a Blood Transfusion
2; 4
SECONDARY
Total Bilirubin
17.70; 18.46

Eligibility Criteria

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02197481) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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