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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatic Resection
 Procedure: Clamp-Crush technique
Procedure: Stapler hepatectomy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clamp-Crushing vs. Stapler Hepatectomy for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH - A Randomized Controlled Trial

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Intraoperative blood loss [ Time Frame: 2.5 hours ] [ Designated as safety issue: Yes ]

Enrollment: 130
Study Start Date: January 2010
Study Completion Date: March 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Clamp-Crush technique 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.
Experimental: Stapler hepatectomy 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01049607

Locations
Germany
Department of General, Visceral and Transplantation Surgery, University of Heidelberg
Heidelberg, BW, Germany, 69120
Sponsors and Collaborators
Nuh Rahbari
Investigators
Principal Investigator: Jürgen Weitz, MD, MSc Department of General, Visceral and Transplantation Surgery, University of Heidelberg
  More Information

No publications provided by University of Heidelberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nuh Rahbari, M.D. Resident, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01049607     History of Changes
Other Study ID Numbers: NNR-03
Study First Received: January 13, 2010
Last Updated: May 16, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
Patients undergoing hepatic resection

ClinicalTrials.gov processed this record on June 18, 2013