RESUMO
This study was designed to demonstrate non-inferiority of robot-assisted total pancreatectomy (RATP) to open total pancreatectomy (OPT) based on an intention-to-treat analysis, having occurrence of severe post-operative complications (SPC) as primary study endpoint. The two groups were matched (2:1) by propensity scores. Assuming a rate of SPC of 22.5% (non-inferiority margin: 15%; α: 0.05; ß: 0.20; power: 80%), a total of 25 patients were required per group. During the study period (October 2008-December 2019), 209 patients received a total pancreatectomy. After application of exclusion and inclusion criteria, matched groups were extracted from an overall cohort of 132 patients (OPT: 107; RATP: 25). Before matching, the two groups were different with respect to prevalence of cardiac disease (24.3% versus 4.0%; p = 0.03), presence of jaundice (45.8% versus 12.0%; p = 0.002), presence of a biliary drainage (23.4% versus 0; p = 0.004), history of weight loss (28.0% versus 8.0%; p = 0.04), and vein involvement (55.1% versus 28.0%) (p = 0.03). After matching, the two groups (OTP: 50; RATP: 25) were well balanced. Regarding primary study endpoint, SPC developed in 13 patients (26.0%) after OTP and in 6 patients (24.0%) after RATP (p = 0.85). Regarding secondary study endpoints, RATP was associated with longer median operating times [475 (408.8-582.5) versus 585 min (525-637.5) p = 0.003]. After a median follow-up time of 23.7 months (10.4-71), overall survival time [22.6 (11.2-81.2) versus NA (27.3-NA) p = 0.006] and cancer-specific survival [22.6 (11.2-NA) versus NA (27.3-NA) p = 0.02] were improved in patients undergoing RATP. In carefully selected patients, robot-assisted total pancreatectomy is non-inferior to open total pancreatectomy regarding occurrence of severe post-operative complications.
