Stapler vs. LigaSure in Elective Hepatic Resection (CRUNSHII)

Heidelberg University

Status: Completed

Conditions: Liver Resection

Treatments: Procedure: Stapler hepatectomy; Device: Ligasure; Other: vascular staple; Procedure: LigaSure hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01858987

NNR-08

Details and patient eligibility

About

The optimal technique of parenchymal transection in liver surgery has remained a matter of controversial debate among hepatobiliary surgeons. The optimal technique should enable secure sealing of the vascular and biliary structures that results in low intraoperative blood loss as well as low postoperative complication rates. Although numerous devices have been introduced and are used widely, high-level evidence, randomized controlled trials, that evaluate efficacy and safety of these devices are scarce. In the present randomized controlled trial two techniques of hepatic resection using vascular staplers and the LigaSure vessel sealing device are compared. While the primary endpoint is intraoperative blood loss a set of general and surgical variables will be analyzed to evaluate efficacy and safety of both methods.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for elective hepatic resection
• Parenchymal transection by vascular stapler and LigaSure feasible
• Age equal or greater than 18 years
• Informed consent

Exclusion criteria

• Extrahepatic resection required based on preoperative imaging
• Participation in concurrent surgical intervention trials
• Expected lack of compliance
• Impaired mental state or language problems

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups

Stapler hepatectomy

Active Comparator group

Description:

Liver resection using vascular stapler for transection of the parenchyma

Treatment:

Procedure: Stapler hepatectomy

Other: vascular staple

LigaSure Hepatectomy

Experimental group

Description:

Liver resection using LigaSure for transection of the parenchyma

Treatment:

Device: Ligasure

Procedure: LigaSure hepatectomy