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

Hepatobiliary Disease Clinical Trial

Official title:

BiClamp Forceps Liver Transection Versus Clamp Crushing Technique in Liver Resections: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197481
• Other study ID #: ahykdxdefsyy10
• Status: Completed
• Phase: Phase 3
• First received: July 15, 2014
• Last updated: May 6, 2017
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2017
• Source: The Second Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatobiliary Disease

Intervention

Procedure:
• Clamp-Crushing technique
Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps

Device:
• BiClamp forceps
liver transection during hepatectomy by BiClamp forceps

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Anhui Medical University	The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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/s00595-012-030 — View 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. 200 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Liver Transection Time	liver transection time was calculated from the beginning to the end of the liver resection	an expected average of 40 minutes
Secondary	Mortality	Operative mortality was defined as any death resulting from a complication during surgery	90 days
Secondary	Morbidity		90 days
Secondary	Biliary Leakage	Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems	90 days
Secondary	Duration of Postoperative Hospital Stay	Time from day of operation to day of discharge	an expected average of 12 days
Secondary	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
Secondary	Total Bilirubin	serum total bilirubin on 3 postoperative day (umol/L)	3 postoperative day