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

NCT02197481 | Completed Phase 3 Results DMC

• 1 other identifier: ahykdxdefsyy10
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatobiliary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Liver Transection Time

  an expected average of 40 minutes

• Mortality

  90 days

• Morbidity

  90 days

• Biliary Leakage

  90 days

• Duration of Postoperative Hospital Stay

  an expected average of 12 days

Study Arms (2)

Clamp-Crushing technique

ACTIVE COMPARATOR

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

Procedure: Clamp-Crushing technique

BiClamp forceps hepatectomy

EXPERIMENTAL

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

Interventions

Clamp-Crushing technique PROCEDURE

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

Clamp-Crushing technique

BiClamp forceps DEVICE

liver transection during hepatectomy by BiClamp forceps

BiClamp forceps hepatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Anhui Medical University: lead
• The First Affiliated Hospital of Anhui Medical University: collaborator

Study Sites (1)

the Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

Related Publications (4)

• 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.

  PMID: 12796583 RESULT

• 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.

  PMID: 19160307 RESULT

• 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.

  PMID: 22993104 RESULT

• 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.

  PMID: 25925431 DERIVED

MeSH Terms

Conditions

Digestive System Diseases

Limitations and Caveats

Owing to the small number of patients, no subgroup analysis based in type of hepatic resection or hepatic portal occlusion, So it is unclear whether the advantage of BiClamp® forceps is applicable to special type hepatic resection subgroups.

Results Point of Contact

• Title: Dr.Jiang-ming Chen
• Organization: The Second Affiliated Hospital of Anhui Medical University

chenjm10@126.com

15855518651

Study Officials

• Geng Xiaoping

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice-president

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 22, 2014
• Study Start: September 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 14, 2017
• Results First Posted: December 14, 2017

Record last verified: 2017-05

Locations

CN (1)