Stapler vs. LigaSure in Elective Hepatic Resection

Study Overview
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Brief Summary
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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.

Official Title
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Stapler vs. LigaSure for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH II - A Randomized Controlled Trial

Conditions
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Liver Resection

Intervention / Treatment
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* Procedure: Stapler hepatectomy
* Procedure: LigaSure hepatectomy
* Device: Ligasure
* Other: vascular staple


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stapler hepatectomy<br>Liver resection using vascular stapler for transection of the parenchyma | Procedure: Stapler hepatectomy<br>* Liver resection using vascular stapler for transection of the parenchyma<br>Other: vascular staple<br> <br> |
| Experimental: LigaSure Hepatectomy<br>Liver resection using LigaSure for transection of the parenchyma | Procedure: LigaSure hepatectomy<br>* Liver resection using LigaSure for transection of the parenchyma<br>Device: Ligasure<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Blood loss | Intraoperative blood loss represents the primary efficacy endpoint of the CRUNSH II-Trial. To obtain a more precise estimate for the individual patient patient's individual transection area will be considered as a continuous covariate in the analysis of covariance (ANOVA). The transection area will be assessed using an imprint of the resected specimen on a paper sheet with a known density of 80 mg/m2. The marked paper area will be cut and weight to calculate the transection area. Intraoperative blood loss will be measured according to the blood collected in the suction containers. Spilling water and ascites will be subtracted. Furthermore, swabs will be squeezed and their content will also be sucked and added to the fluid collected in the suction containers. Central venous pressure will be lowered below 5 cmH2O for the transection period. | Beginning to end of surgical procedure |