Trial sequential meta-analysis of laparoscopic versus open pancreaticoduodenectomy: is it the time to stop the randomization?

Abstract

Background The advantages of LPD compared with OPD remain debatable. The study aimed to compare the laparoscopic (LPD) versus open (OPD) for pancreaticoduodenectomy. Methods A meta-analysis of randomized studies (RCTs) comparing LPD and OPD was made. The results were reported as relative risk (RRs) or mean differences (MDs). The trial sequential analysis was used to test the type I and type II errors defining the required information size (RIS). The primary outcome was mortality, major morbidity, and postoperative pancreatic fistula (POPF). R1 resection, post-pancreatectomy hemorrhage, delayed gastric emptying, biliary fistula, reoperation, readmission, operative time (OT), lymph nodes harvested, and length of stay (LOS) were also studied. Results Four RCTs, counting 818 patients, were found. The RRs for mortality, major morbidity, and POPF were 1.16, 1.04, and 0.86, without significant differences. The RISs were 35,672, 16,548, and 8206. To confirm this equivalence, at least 34,854, 15,730, and 7338 should be randomized. OT was significantly longer in LPD than OPD, with an MD of 63.22. The LOS was significantly shorter in LPD than in OPD, with − 1.76 days. The RISs were 1297 and 1273, excluding a false-positive result. No significant differences were observed for the remaining endpoints, and RISs suggested that more than 3000 patients should be randomized to confirm the equivalence. Conclusion The equivalence of LPD and OPD for mortality, major morbidity, and POPF is affected by type II error. The RISs to demonstrate a superiority of one of the two techniques seem unrealistic to obtain.

Is open pancreatic surgery still relevant now in the era of minimally invasive pancreatic surgery?

“…Trial sequential analysis by Ricci et al in 2023 showed that for laparoscopic pancreaticoduodenectomy (LPD) to reduce the relative risk (RR) of POPF by 25%, a cumulative sample size of 2,755 was required (only 818 patients were included in their review). They concluded that it is impossible to recruit enough patients for randomized controlled trials (RCTs) to show the benefit of MIPS in the near future ( 2 ). Nevertheless, there is an increasing adoption of MIPS, from 10% in 2010 to 13% in 2014 for laparoscopic pancreatic surgery (LPS), and from <1% in 2010 to 3% in 2014 for robotic pancreatic surgery (RPS) in the United States ( 3 ).…”