Stapler Hepatectomy for Elective Liver Resection

Phase 3

Completed

• Conditions: Hepatic Resection
• Interventions: Procedure: Clamp-Crush technique; Procedure: Stapler hepatectomy

• Registration Number: NCT01049607
• Lead Sponsor: Nuh Rahbari

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-13
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Primary Completion: 2011-10
• Study Completion: 2012-03
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clamp-Crush technique	Clamp-Crush technique	-
Stapler hepatectomy	Stapler hepatectomy	-

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss	2.5 hours

Trial Locations

Locations (1)

Department of General, Visceral and Transplantation Surgery, University of Heidelberg; 🇩🇪 Heidelberg, BW, Germany