Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention.The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection.ClinicalTrials.gov: NCT01049607Hepatic resection forms the cornerstone of therapy for a variety of benign and malignant diseases of the liver [1]. While advances in patient selection, surgical technique, perioperative management and imaging tools reduced mortality substantially, morbidity of patients undergoing hepatic resection remains as high as 30-60% even at high-volume centers [2-7]. Due to the risk of intraoperative hemorrhage as well as postoperative morbidity (e.g. bile leakage, posthepatectomy hemorrhage), the period of actual transection of the liver parenchyma represents a crucial step during hepatic resection. Various studies could indeed demonstrate intraoperative hemorrhage as predictor of poor perioperative outcome in patients undergoing hepatic resection [1,8]. Although various devices have been developed to facilitate parenchymal transection with the ultimate aim to reduce intraoperative blood loss [9], a recent systematic review and meta-analysis failed to show a benefit of these tools compared to the simple clamp-crushing technique [10]. However, to the present there is no randomized controlled trial