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OpenTrials
Completed

NCT Number: NCT01858987

Stapler vs. LigaSure in Elective Hepatic Resection

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.

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Key information

Conditions

Liver Resection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospital Dresden

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stapler hepatectomy

Procedure

Liver resection using vascular stapler for transection of the parenchyma

LigaSure hepatectomy

Procedure

Liver resection using LigaSure for transection of the parenchyma

LIGASURE

Device

vascular staple

Other

Primary outcomes

  1. Intraoperative Blood loss

    Time frame: Beginning to end of surgical procedure

    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.

Sponsors and collaborators

Lead sponsor

Heidelberg University

Other

Registry information

Official study title

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

Acronym: CRUNSHII

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 21, 2013
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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