Stapler Hepatectomy for Elective Liver Resection

Hepatic Resection Clinical Trial

— CRUNSH  

Official title:

Clamp-Crushing vs. Stapler Hepatectomy for Transection of the Parenchyma in Elective Hepatic Resection: CRUNSH - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049607
• Other study ID #: NNR-03
• Status: Completed
• Phase: Phase 3
• First received: January 13, 2010
• Last updated: May 16, 2013
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2013
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: March 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Resection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Department of General, Visceral and Transplantation Surgery, University of Heidelberg	Heidelberg	BW

Sponsors (1)

Lead Sponsor	Collaborator
Nuh Rahbari

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss		2.5 hours	Yes