Distal Pancreatectomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection (DISPACT-2 trial)

• Applicant: Privatdozentin Dr. Rosa Klotz, since 12/2021
• Subject Area: General and Visceral Surgery
• Term: since 2020
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 405679401

The DISPACT-2 trial (DIstal PAncreateCTomy – A randomised controlled trial to compare minimal-invasive distal pancreatectomy to open resection) is a prospective randomised controlled open-label multicentre surgical trial with two parallel study groups. The trial evaluates differences of postoperative morbidity as well as further clinical and oncological effectiveness, surgical safety, quality of life and costs between minimal-invasive and open distal pancreatectomy. Patient related outcomes are not only affected by underlying disease, but also by the open approach with its increased surgical trauma. Endoscopic surgery with its reduced invasiveness promises reduction of postoperative pain, subsequent better mobilisation and less respiratory complications leading to a quicker recovery and better quality of life. Systematic reviews comparing laparoscopic with open distal pancreatectomy found length of hospital stay, blood loss and time to first oral intake to be improved in the laparoscopic group. However, no significant difference was found in postoperative complications. Yet, all data are based on non-randomised studies and a selection bias is likely in the existing evidence. Therefore, a randomised controlled trial is urgently needed to assess the effectiveness prior to general implementation. The primary hypothesis is that minimal-invasive resection is non-inferior to the open approach in terms of postoperative morbidity and mortality. A total of 294 randomised patients with malignant or benign diseases of the pancreas will be needed to proof this hypothesis. Moreover, patient related and oncological outcomes will be assessed. In presence of an equal postoperative morbidity the minimal-invasive approach could then be offered to patients as first choice based on the highest level of evidence.

• DFG Programme: Clinical Trials
• Co-Investigators: Professor Dr. Thilo Hackert; Professor Dr. Arianeb Mehrabi; Professor Dr. Beat Peter Müller-Stich
• Ehemalige Antragsteller: Professor Dr. Markus K. Diener, until 11/2020; Professor Dr. Pascal Probst, from 11/2020 until 12/2021