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

• ClinicalTrials.gov Identifier: NCT02197481
• Recruitment Status: Completed
• First Posted: July 22, 2014
• Results First Posted: December 14, 2017
• Last Update Posted: December 14, 2017
• Sponsor: The Second Hospital of Anhui Medical University
• Collaborator: The First Affiliated Hospital of Anhui Medical University
• Information provided by (Responsible Party): xpgeng, The Second Hospital of Anhui Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hepatobiliary Disease	Procedure: Clamp-Crushing technique; Device: BiClamp forceps	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial
• Study Start Date: September 2014
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: May 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

China, Anhui

the Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230022

Sponsors and Collaborators

The Second Hospital of Anhui Medical University

The First Affiliated Hospital of Anhui Medical University

Investigators

• Principal Investigator: Geng Xiaoping; The Second Hospital of Anhui Medical University

More Information

Study Data/Documents: Study Protocol 

Identifier: PMID:25925431

Publications of Results:

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.

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. Review.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen JM, Geng W, Liu FB, Zhao HC, Xie SX, Hou H, Zhao YJ, Wang GB, Geng XP. BiClamp® 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.

• Responsible Party: xpgeng, vice-president, The Second Hospital of Anhui Medical University
• ClinicalTrials.gov Identifier: NCT02197481
• Other Study ID Numbers: ahykdxdefsyy10
• First Posted: July 22, 2014
• Results First Posted: December 14, 2017
• Last Update Posted: December 14, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by xpgeng, The Second Hospital of Anhui Medical University:

BiClamp forceps hepatectomy; Clamp crushing technique; Liver parenchyma transection; Randomized controlled trial

Additional relevant MeSH terms:

Digestive System Diseases; Liver Diseases