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

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.

Study Overview

• Status: Completed
• Conditions: Hepatobiliary Disease
• Intervention / Treatment: Procedure: Clamp-Crushing technique; Device: BiClamp forceps

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • The Second Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Clamp-Crushing technique; liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted	Procedure: Clamp-Crushing technique; Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
EXPERIMENTAL: BiClamp forceps hepatectomy; The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.	Device: BiClamp forceps; liver transection during hepatectomy by BiClamp forceps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Total Blood Loss	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	an expected average of 80 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity		90 days
Mortality	Operative mortality was defined as any death resulting from a complication during surgery	90 days
Liver Transection Time	liver transection time was calculated from the beginning to the end of the liver resection	an expected average of 40 minutes
Biliary Leakage	Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems	90 days
Duration of Postoperative Hospital Stay	Time from day of operation to day of discharge	an expected average of 12 days
Number of Participants Requiring a Blood Transfusion	Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively	2 days
Total Bilirubin	serum total bilirubin on 3 postoperative day (umol/L)	3 postoperative day

Collaborators and Investigators

• Sponsor: The Second Hospital of Anhui Medical University
• Collaborators: The First Affiliated Hospital of Anhui Medical University
• Investigators: Principal Investigator: Geng Xiaoping, The Second Hospital of Anhui Medical University

Publications and helpful links

General Publications

• 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.
• Gurusamy KS, Pamecha V, Sharma D, Davidson BR. Techniques for liver parenchymal transection in liver resection. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD006880. doi: 10.1002/14651858.CD006880.pub2.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (ESTIMATE): July 22, 2014

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2017
• Last Update Submitted That Met QC Criteria: May 6, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Randomized controlled trial; BiClamp forceps hepatectomy; Clamp crushing technique; Liver parenchyma transection
• Additional Relevant MeSH Terms: Liver Diseases; Digestive System Diseases
• Other Study ID Numbers: ahykdxdefsyy10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Study Data/Documents

1. Study Protocol
   Information identifier: PMID:25925431