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Protocol for a randomised controlled trial to compare postoperative complications between minimally invasive and open
Pascal Probst1,2, Fabian Schuh3,2, Colette Dörr-Harim2
1Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany pascal.probst@med.uni-heidelberg.de.
Introduction:
In 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 Analysis:
DISPACT-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 Dissemination:
The 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 Number:
DRKS00014011.
Insights
Minimally invasive distal pancreatectomy (MIDP) shows promise for faster patient recovery. The DISPACT-2 trial compares MIDP to open surgery to determine if it is non-inferior in reducing complications.
Area of Science:
- Surgical Oncology
- Gastroenterology
- Minimally Invasive Surgery
Background:
- Minimally invasive distal pancreatectomy (MIDP) is increasingly used for patient recovery.
- Distal pancreatectomy carries a 30%-40% morbidity rate.
- Evidence is needed to compare MIDP advantages against open surgery.
Purpose of the Study:
- To compare minimally invasive (laparoscopic or robotic) with open distal pancreatic resection.
- To assess if MIDP is non-inferior to open surgery regarding postoperative mortality and morbidity.
- To evaluate secondary endpoints including pancreas-specific complications, oncological safety, and patient-reported outcomes.
Main Methods:
- The DISPACT-2 is a multicentre randomised controlled trial.
- 294 adult patients undergoing elective distal pancreatectomy for benign or malignant diseases were randomized 1:1.
- The primary outcome is non-inferiority of MIDP versus open surgery based on the Comprehensive Complication Index (CCI) within 3 months, with a 7.5 CCI point margin.
Main Results:
- Primary endpoint results are anticipated in 2024.
- The study will provide data on the comparative effectiveness of MIDP versus open distal pancreatectomy.
- The trial involves a 2-year follow-up for each patient.
Conclusions:
- The DISPACT-2 trial will provide crucial data on the safety and efficacy of MIDP.
- Findings will inform clinical practice regarding the implementation of minimally invasive techniques in distal pancreatectomy.
- Publication in an open-access, peer-reviewed journal is planned.