Clinical trial NCT01049607: Stapler Hepatectomy for Elective Liver Resection
Official title: Clamp-Crushing vs. Stapler Hepatectomy for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatic Resection
Keywords: Patients undergoing hepatic resection
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-01-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is clinical uncertainty and ongoing discussion among liver surgeons regarding the optimal method of parenchymal transection in patients undergoing elective hepatic resection. While the clamp-crushing technique still represents the reference technique for routine liver resections, transection of liver parenchyma using vascular staplers may offer a new and safe technique potentially reducing intraoperative blood loss, operation time as well as peri-operative morbidity. As morbidity of patients undergoing hepatic resection remains high, approaches to lower peri-operative complications are urgently required. Due to the lack of evidence it has to be evaluated, if the technique of stapler hepatectomy decreases intraoperative blood loss as a highly relevant predictor of peri-operative complications, patients' hospital stay and finally health care expenditures. These advantages would favor stapler hepatectomy to be applied in routine liver resections. As RCTs are generally considered to generate the most valid scientific evidence on a treatment's effects, the present trial evaluates potential benefits of stapler hepatectomy in a randomized fashion.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective hepatic resection
* Stapler hepatectomy and clamp-crushing feasible based on preoperative imaging
* Age equal or greater than 18 years
* Informed consent

Exclusion Criteria:

* Participation in concurrent intervention trials
* Expected lack of compliance
* Impaired mental state or language problems

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: 2.5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of General, Visceral and Transplantation Surgery, University of Heidelberg
state: BW
Study officials:
affiliation: Department of General, Visceral and Transplantation Surgery, University of Heidelberg
name: Jürgen Weitz, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahbari NN, Elbers H, Koch M, Vogler P, Striebel F, Bruckner T, Mehrabi A, Schemmer P, Buchler MW, Weitz J. Randomized clinical trial of stapler versus clamp-crushing transection in elective liver resection. Br J Surg. 2014 Feb;101(3):200-7. doi: 10.1002/bjs.9387. Epub 2014 Jan 8.
citation: Rahbari NN, Elbers H, Koch M, Bruckner T, Vogler P, Striebel F, Schemmer P, Mehrabi A, Buchler MW, Weitz J. Clamp-crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH)--a randomized controlled trial (NCT01049607). BMC Surg. 2011 Sep 4;11:22. doi: 10.1186/1471-2482-11-22.