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

NCT ID: NCT02197481

Last Updated: 2017-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Hepatobiliary Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clamp-Crushing technique

liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted

Group Type ACTIVE_COMPARATOR

Clamp-Crushing technique

Intervention Type PROCEDURE

Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps

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.

Group Type EXPERIMENTAL

BiClamp forceps

Intervention Type DEVICE

liver transection during hepatectomy by BiClamp forceps

Interventions

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Clamp-Crushing technique

Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps

Intervention Type PROCEDURE

BiClamp forceps

liver transection during hepatectomy by BiClamp forceps

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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xpgeng

vice-president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Geng Xiaoping

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Anhui Medical University

Locations

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the Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 12796583 (View on PubMed)

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.

Reference Type RESULT
PMID: 19160307 (View on PubMed)

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.

Reference Type RESULT
PMID: 22993104 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25925431 (View on PubMed)

Study Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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ahykdxdefsyy10

Identifier Type: -

Identifier Source: org_study_id