Protocol for a randomised controlled trial to compare postoperative complications between minimally invasive and open DIStal PAnCreaTectomy (DISPACT-2 trial)

Abstract

IntroductionIn recent years, minimally invasive distal pancreatectomy (MIDP) has been used with increasing frequency to accelerate patient recovery. Distal pancreatectomy has an overall morbidity rate of 30%–40%. The known advantages of minimally invasive techniques must be rigorously compared with those of open surgery before they can be completely implemented into clinical practice.Methods and analysisDISPACT-2 is a multicentre randomised controlled trial comparing minimally invasive (conventional laparoscopic or robotic assisted) 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 MIDP is non-inferior to open distal pancreatectomy in terms of postoperative mortality and morbidity expressed 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 2 years.Ethics and disseminationThe DISPACT-2 trial has been approved by the Ethics Committee of the medical faculty of Heidelberg University (S-693/2017). Results of the primary endpoint will be available in 2024 and will be published at national and international meetings. Full results will be made available in an open access, peer-reviewed journal. The website www.dispact.de contains up-to-date information regarding the trial.Trial registration numberDRKS00014011

Effects of Pancreatic Surgery : Quality of Life, Cost-effectiveness and Postoperative Results

“…As of writing, there are several ongoing RCTs comparing open to minimally invasive pancreatic resections. 42,178,179 IMPLEMENTATION OF QUALITY OF LIFE DATA…”

Prince and princesses: The current status of robotic surgery in surgical oncology

“…[57][58][59] There are two more ongoing RCTs investigating RDP. 60,61 Currently, no RCTs exist for robotic pancreaticoduodenectomy.…”

Pancreatic Cancer: Current Multimodality Treatment Options and the Future Impact of Molecular Biological Profiling

“…On the other hand, a recent meta-analysis of three RCTs demonstrated no differences between laparoscopic and open partial pancreatoduodenectomy in terms of morbidity and mortality despite a lower blood loss and longer duration of surgery in the laparoscopic group [9]. Various trials are currently on the way to shed more light on the topic of minimally invasive versus open surgery for PDAC including robotic surgery [10, 11].…”