Stapler Hepatectomy for Elective Liver Resection (CRUNSH)

• ClinicalTrials.gov Identifier: NCT01049607
• Recruitment Status: Completed
• First Posted: January 14, 2010
• Last Update Posted: May 17, 2013
• Sponsor: Nuh Rahbari
• Information provided by (Responsible Party): Nuh Rahbari, Heidelberg University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hepatic Resection	Procedure: Clamp-Crush technique; Procedure: Stapler hepatectomy	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: January 2010
• Actual Primary Completion Date: October 2011
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Intraoperative blood loss [ Time Frame: 2.5 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

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

Rahbari NN, Elbers H, Koch M, Vogler P, Striebel F, Bruckner T, Mehrabi A, Schemmer P, Büchler 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.

Rahbari NN, Elbers H, Koch M, Bruckner T, Vogler P, Striebel F, Schemmer P, Mehrabi A, Büchler 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.

• Responsible Party: Nuh Rahbari, M.D. Resident, Heidelberg University
• ClinicalTrials.gov Identifier: NCT01049607
• Other Study ID Numbers: NNR-03
• First Posted: January 14, 2010
• Last Update Posted: May 17, 2013
• Last Verified: May 2013

Keywords provided by Nuh Rahbari, Heidelberg University:

Patients undergoing hepatic resection