Minimally invasive versus open distal pancreatectomy (LEOPARD): study protocol for a randomized controlled trial

Area of Science:

• Surgical Oncology
• Gastroenterology
• Clinical Trials

Background:

• Observational studies suggest minimally invasive distal pancreatectomy (MIDP) offers better short-term outcomes than open distal pancreatectomy (ODP).
• Confounding by indication may limit findings from observational studies; case-matched studies have not confirmed MIDP superiority.
• There is a need for multicenter randomized controlled trials to definitively compare MIDP and ODP.

Purpose of the Study:

• To test the hypothesis that time to functional recovery is shorter after MIDP compared to ODP.
• To evaluate MIDP versus ODP within an enhanced recovery setting.
• To provide evidence from a multicenter randomized controlled trial to guide surgical practice.

Main Methods:

• The LEOPARD trial is a randomized controlled, patient-blinded, multicenter superiority trial.
• 102 patients with symptomatic benign, premalignant, or malignant disease will be randomized to MIDP or ODP.
• Primary outcome is time to functional recovery; secondary outcomes include operative/postoperative outcomes, complications, mortality, quality of life, and costs.

Main Results:

• This section is not applicable as the abstract does not contain results.
• The LEOPARD trial is ongoing and results are pending.
• No results are available at this time.

Conclusions:

• The LEOPARD trial aims to determine if MIDP reduces time to functional recovery compared to ODP in an enhanced recovery setting.
• Findings will clarify the comparative effectiveness of minimally invasive versus open distal pancreatectomy.
• The study addresses a critical gap in evidence regarding surgical approaches for distal pancreatectomy.