Stapler Hepatectomy for Elective Liver Resection (CRUNSH)

Nuh Rahbari

Status and phase: Completed; Phase 3

Conditions: Hepatic Resection

Treatments: Procedure: Clamp-Crush technique; Procedure: Stapler hepatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01049607

NNR-03

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Clamp-Crush technique

Active Comparator group

Treatment:

Procedure: Clamp-Crush technique

Stapler hepatectomy

Experimental group

Treatment:

Procedure: Stapler hepatectomy