Stapler Hepatectomy for Elective Liver Resection (CRUNSH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nuh Rahbari, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01049607
First received: January 13, 2010
Last updated: May 16, 2013
Last verified: May 2013

January 13, 2010
May 16, 2013
January 2010
October 2011   (final data collection date for primary outcome measure)
Intraoperative blood loss [ Time Frame: 2.5 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01049607 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Stapler Hepatectomy for Elective Liver Resection
Clamp-Crushing vs. Stapler Hepatectomy for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH - A Randomized Controlled Trial

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Hepatic Resection
  • Procedure: Clamp-Crush technique
    The transectional line is marked and the liver capsule is cauterized. The liver parenchyma is then crushed stepwise using a regular Pèan clamp. Vessels and bile ducts are ligated or clipped. Vessels of less than 2mm diameter are coagulated with the irrigated bipolar forceps.
  • Procedure: Stapler hepatectomy
    The transectional line is marked and the liver capsule is cauterized. For subsequent transection of the hepatic parenchyma, the liver tissue is fractured with a vascular clamp in a stepwise fashion and subsequently divided with endo GIA vascular staplers.
  • Active Comparator: Clamp-Crush technique
    Intervention: Procedure: Clamp-Crush technique
  • Experimental: Stapler hepatectomy
    Intervention: Procedure: Stapler hepatectomy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
March 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01049607
NNR-03
No
Nuh Rahbari, University of Heidelberg
Nuh Rahbari
Not Provided
Principal Investigator: Jürgen Weitz, MD, MSc Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP