Minimally invasive versus open pancreatoduodenectomy (LEOPARD-2): study protocol for a randomized controlled trial

Area of Science:

• Surgical Oncology
• Gastroenterology
• Clinical Trials

Background:

• Observational studies suggest minimally invasive pancreatoduodenectomy (MIPD) offers benefits over open surgery, including less blood loss and shorter hospital stays.
• However, evidence is conflicting, with some studies showing no superiority and US registry data indicating potential increased mortality for MIPD in low-volume centers.
• Randomized controlled trials are needed to definitively compare MIPD and open pancreatoduodenectomy.

Purpose of the Study:

• To evaluate if minimally invasive pancreatoduodenectomy (MIPD) leads to a shorter time to functional recovery compared to open pancreatoduodenectomy.
• To assess secondary outcomes including operative and postoperative complications, mortality, quality of life, and costs within an enhanced recovery setting.

Main Methods:

• The LEOPARD-2 trial is a randomized, patient-blinded, multicenter, phase 2/3 superiority trial.
• 136 patients will be randomized to undergo either minimally invasive or open pancreatoduodenectomy in an enhanced recovery setting.
• Patients will be blinded to the surgical approach until at least postoperative day 5.

Main Results:

• This section is not yet available as the study is ongoing.
• The primary outcome is time to functional recovery.
• Secondary outcomes include complications, mortality, quality of life, and costs.

Conclusions:

• The LEOPARD-2 trial aims to determine if minimally invasive pancreatoduodenectomy (MIPD) improves functional recovery time compared to open pancreatoduodenectomy.
• Results will inform clinical practice regarding the optimal surgical approach for pancreatoduodenectomy within enhanced recovery protocols.