GZ PR 1651/1-1 DI 1484/4-1

Trial Protocol

DISPACT-2 is a multicentre randomised controlled blinded trial comparing minimal-invasive with open distal pancreatic resection in patients undergoing elective surgery for benign as well as malign diseases of the pancreatic body and tail.

After screening for eligibility and obtaining informed consent a total of 294 adult patients will be preoperatively randomised in a 1:1 ratio. The primary hypothesis is that minimal-invasive distal pancreatectomy (MIDP) is non-inferior to open distal pancreatectomy (ODP) in terms of postoperative mortality and morbidity measured as the comprehensive complication index (CCI) within 3 months after index operation with a non-inferiority margin of 7.5 CCI points. Secondary endpoints include pancreas specific complications, oncological safety and patient reported outcomes. Follow-up for each individual patient will be two years.

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