Clinical trial NCT02197481: Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial
Official title: BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatobiliary Disease
Keywords: BiClamp forceps hepatectomy
Clamp crushing technique
Liver parenchyma transection
Randomized controlled trial
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Anhui Medical University
First posted: 2014-07-22
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 \<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

Primary outcomes:
measure: The Total Blood Loss
timeFrame: an expected average of 80 minutes
Secondary outcomes:
measure: Liver Transection Time
timeFrame: an expected average of 40 minutes
measure: Mortality
timeFrame: 90 days
measure: Morbidity
timeFrame: 90 days
measure: Biliary Leakage
timeFrame: 90 days
measure: Duration of Postoperative Hospital Stay
timeFrame: an expected average of 12 days
measure: Number of Participants Requiring a Blood Transfusion
timeFrame: 2 days
measure: Total Bilirubin
timeFrame: 3 postoperative day
Other outcomes:
Locations:
city: Hefei
country: China
facility: the Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Geng Xiaoping
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kooby DA, Stockman J, Ben-Porat L, Gonen M, Jarnagin WR, Dematteo RP, Tuorto S, Wuest D, Blumgart LH, Fong Y. Influence of transfusions on perioperative and long-term outcome in patients following hepatic resection for colorectal metastases. Ann Surg. 2003 Jun;237(6):860-9; discussion 869-70. doi: 10.1097/01.SLA.0000072371.95588.DA.
citation: Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.
citation: Itoh S, Fukuzawa K, Shitomi Y, Okamoto M, Kinoshita T, Taketomi A, Shirabe K, Wakasugi K, Maehara Y. Impact of the VIO system in hepatic resection for patients with hepatocellular carcinoma. Surg Today. 2012 Dec;42(12):1176-82. doi: 10.1007/s00595-012-0306-6. Epub 2012 Sep 20.
citation: Chen JM, Geng W, Liu FB, Zhao HC, Xie SX, Hou H, Zhao YJ, Wang GB, Geng XP. BiClamp(R) forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial. Trials. 2015 Apr 30;16:201. doi: 10.1186/s13063-015-0722-1.