Phase 3
N=86
Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial
Hepatobiliary Disease
Bottom Line
View on ClinicalTrials.gov: NCT02197481 ↗Enrolled (actual)
86
Serious AEs
7.0%
Results posted
Dec 2017
Primary outcome: Primary: The Total Blood Loss — 376.73; 339.81 ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Clamp-Crushing technique (Procedure); BiClamp forceps (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Second Hospital of Anhui Medical University
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02197481). 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.