NCT01858987: CRUNSHII

Stapler vs. LigaSure in Elective Hepatic Resection

Completed NA Last updated 9 October 2017

What this trial tests

NA trial testing Stapler hepatectomy in Liver Resection in 138 participants. Completed in 14 August 2014.

Timeline

2 November 2011

Primary endpoint
17 July 2014

14 August 2014

Quick facts

Lead sponsor	Heidelberg University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	138
Start date	2 November 2011
Primary completion	17 July 2014
Estimated completion	14 August 2014
Sites	1 location across Germany

Drugs / interventions tested

• Stapler hepatectomy
• LigaSure hepatectomy
• Ligasure
• vascular staple

Conditions studied

• Liver Resection — all drugs for Liver Resection →

Sponsor

Heidelberg University

Who can join

18 and older, any sex, with Liver Resection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Randomized clinical trial of stapler hepatectomy versus LigaSure™ transection in elective hepatic resection.
   Fritzmann J, Kirchberg J, Sturm D, Ulrich AB, et al · · 2018 · cited 17× · PMID 30069876 · DOI 10.1002/bjs.10902
2. Infrahepatic Inferior Vena Cava Clamping does not Increase the Risk of Pulmonary Embolism Following Hepatic Resection.
   Birgin E, Mehrabi A, Sturm D, Reißfelder C, et al · · 2021 · cited 7× · PMID 34047820 · DOI 10.1007/s00268-021-06159-4