Abstract
BACKGROUND: Complications after pancreatoduodenectomy occur in up to 40% of patients. Postoperative pancreatic fistula (POPF) remains the most common complication after pancreatoduodenectomy and is associated with increased postoperative mortality. The cavitron ultrasonic surgical aspirator (CUSA) is a surgical instrument commonly used in liver and neurosurgery. The CUSA selectively dissects tissue parenchyma, leaving blood vessels and bile ducts undamaged, which are then selectively ligated or clipped. Only a few studies have investigated the relationship between the transection of pancreatic tissue with CUSA and the formation of POPF. The results were inconsistent and were published before the updated ISGPS consensus on the definition of POPF. METHODS: The PANCUT study is a randomised controlled trial initiated at the Department of Abdominal Surgery, University Medical Centre Ljubljana. The aim of the study is to determine whether precise dissection of the pancreatic tissue with CUSA reduces the incidence of POPF. Patients scheduled for pancreatoduodenectomy will be randomly assigned to either the experimental group, in which the pancreatic tissue will be dissected with CUSA, or the control group, in which pancreas will be conventionally transected with scalpel. A total of 180 patients will be included in the study. The primary endpoint is the formation of POPF. Secondary endpoints include operation time, amount of intraoperative blood loss, postoperative infectious complications, postoperative bleeding, length of hospital stay and mortality. DISCUSSION: To our knowledge, the PANCUT study is the first randomized controlled trial to investigate the role of CUSA in the transection of pancreatic tissue during pancreatoduodenectomy. TRIAL REGISTRATION: ClinicalTrials.gov NCT06135012. Registered on 18 November 2023.