Stapler vs. LigaSure in Elective Hepatic Resection (CRUNSHII)

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Resection
• Intervention / Treatment: Procedure: Stapler hepatectomy; Other: vascular staple; Procedure: LigaSure hepatectomy; Device: Ligasure

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • UniversityHospital Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heidelberg University

Publications and helpful links

General Publications

• Fritzmann J, Kirchberg J, Sturm D, Ulrich AB, Knebel P, Mehrabi A, Buchler MW, Weitz J, Reissfelder C, Rahbari NN. Randomized clinical trial of stapler hepatectomy versus LigaSure transection in elective hepatic resection. Br J Surg. 2018 Aug;105(9):1119-1127. doi: 10.1002/bjs.10902.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2011
• Primary Completion (Actual): July 17, 2014
• Study Completion (Actual): August 14, 2014

Study Registration Dates

• First Submitted: May 16, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Actual): October 9, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: NNR-08