Disentangling seemingly contradictory results of the first two randomised controlled trials comparing open and robotic pancreatoduodenectomy

摘要

Minimally invasive pancreatoduodenectomy has recently surged in popularity, particularly with the introduction of robotic assistance offering a promising avenue for broader adoption.1Boggi U. Donisi G. Napoli N. et al.Correction to: prospective minimally invasive pancreatic resections from the IGOMIPS registry: a snapshot of daily practice in Italy on 1191 between 2019 and 2022.Updates Surg. 2024; 76: 327-328https://doi.org/10.1007/s13304-023-01709-yCrossref PubMed Scopus (0) Google Scholar Several retrospective studies have demonstrated that robotic pancreatoduodenectomy (RPD) may be comparable to open PD (OPD), although the criteria for patient selection remain contentious.2Napoli N. Kauffmann E.F. Vistoli F. Amorese G. Boggi U. State of the art of robotic pancreatoduodenectomy.Updates Surg. 2021; 73: 873-880https://doi.org/10.1007/s13304-021-01058-8Crossref PubMed Scopus (20) Google Scholar,3Napoli N. Cacace C. Kauffmann E.F. et al.The PD-ROBOSCORE: a difficulty score for robotic pancreatoduodenectomy.Surgery. 2023; 173: 1438-1446https://doi.org/10.1016/j.surg.2023.02.020Summary Full Text Full Text PDF PubMed Scopus (2) Google Scholar Furthermore, while approximately 40 RPD cases are needed to overcome the initial learning curve, the full potential of RPD may not be realized until 250 procedures.4Zhang T. Zhao Z.M. Gao Y.X. Lau W.Y. Liu R. The learning curve for a surgeon in robot-assisted laparoscopic pancreaticoduodenectomy: a retrospective study in a high-volume pancreatic center.Surg Endosc. 2019; 33: 2927-2933https://doi.org/10.1007/s00464-018-6595-0Crossref PubMed Scopus (97) Google Scholar The importance of achieving proficiency in minimally invasive pancreatoduodenectomy before implementing randomised controlled trials (RCTs) was highlighted by the LEOPARD-2 trial, which was closed due to safety concerns.5van Hilst J. De Rooij T. Bosscha K. et al.Laparoscopic versus open pancreatoduodenectomy for pancreatic or periampullary tumours (LEOPARD-2): a multicentre, patient-blinded, randomised con- trolled phase 2/3 trial.Lancet Gastroenterol Hepatol. 2019; 4: 199-207https://doi.org/10.1016/S2468-1253(19)30004-4Summary Full Text Full Text PDF PubMed Scopus (405) Google Scholar In recent weeks, results from two RCTs comparing RPD with OPD have been published, one from Heidelberg (EUROPA trial) and the other from China.6Klotz R. Mihaljevic A.L. Kulu Y. et al.Robotic versus open partial pancreatoduodenectomy (EUROPA): a randomised controlled stage 2b trial.Lancet Reg Health Eur. 2024; 39100864https://doi.org/10.1016/j.lanepe.2024.100864Summary Full Text Full Text PDF PubMed Scopus (1) Google Scholar,7Liu Q. Li M. Gao Y. et al.Effect of robotic versus open pancreaticoduodenectomy on postoperative length of hospital stay and complications for pancreatic head or periampullary tumours: a multicentre, open-label randomised controlled trial.Lancet Gastroenterol Hepatol. 2024; https://doi.org/10.1016/S2468-1253(24)00005-0Summary Full Text Full Text PDF Scopus (1) Google Scholar Notably, a US-based RCT (trial registry: NCT04171440) could not be completed due to difficulties in recruiting patients for OPD and was “converted” into an observational study on perioperative outcomes of RPD. While patients' choices cannot dictate scientific evidence, it is noteworthy that the EUROPA trial saw 12% of patients declining participation, while 21% did so in the Chinese trial. Additionally, in the Chinese trial, 5% of patients initially assigned to OPD underwent RPD due to withdrawal of consent. Table 1 compares key variations between the EUROPA and Chinese trials. The EUROPA trial was a single-centre, investigator-initiated, exploratory (IDEAL stage 2b), open-label RCT without a power calculation, focusing on the comprehensive complication index. Conversely, the Chinese trial was a multicentre superiority phase-3 RCT aiming to demonstrate a reduction in hospital stay with RPD. Both trials were open-label, with participating surgeons having compl