- The randomized LEOPARD-2 trial was stopped early (73% of planned sample size) because of a potentially higher 90-day mortality rate with laparoscopic pancreatoduodenectomy ("Whipple" procedure) vs the open approach.
Why this matters
- The safety issues were unexpected and concerning given that the trial was conducted in centers with experienced surgeons.
- The study is the first patient-blinded trial comparing the 2 approaches.
- In a phase 2/3 trial conducted at 4 centers that performed ≥20 pancreatoduodenectomies per year, 99 patients were randomly assigned to receive open or laparoscopic procedures.
- Funding: Johnson & Johnson Medical BV.
- At 90 days postop, there were 5 complication-related deaths after laparoscopic surgery vs 1 with the open approach (10% vs 2%; risk ratio [RR]=4.90; P=.20).
- Centers conducted a median of 37 pancreatoduodenectomies and 11 laparoscopic pancreatoduodenectomies annually.
- Median operative time was longer in the laparoscopic group (410 vs 274 minutes; P<.0001>
- There was no difference between groups in median time to functional recovery (10 vs 8 days; P=.30).
- Rates of Clavien-Dindo grade 3 or higher complications (50% vs 39%; P=.26), including grade B/C pancreatic fistulas (28% vs 24%; P=.69) were similar between groups.
- Early termination.