TY - JOUR
T1 - Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA)
T2 - an international randomised non-inferiority trial
AU - Korrel, Maarten
AU - Jones, Leia R.
AU - van Hilst, Jony
AU - Balzano, Gianpaolo
AU - Björnsson, Bergthor
AU - Boggi, Ugo
AU - Bratlie, Svein Olav
AU - Busch, Olivier R.
AU - Butturini, Giovanni
AU - Capretti, Giovanni
AU - Casadei, Riccardo
AU - Edwin, Bjørn
AU - Emmen, Anouk M. L. H.
AU - Esposito, Alessandro
AU - Falconi, Massimo
AU - Groot Koerkamp, Bas
AU - Keck, Tobias
AU - de Kleine, Ruben H. J.
AU - Kleive, Dyre B.
AU - Kokkola, Arto
AU - Lips, Daan J.
AU - Lof, Sanne
AU - Luyer, Misha D. P.
AU - Manzoni, Alberto
AU - Marudanayagam, Ravi
AU - de Pastena, Matteo
AU - Pecorelli, Nicolò
AU - Primrose, John N.
AU - Ricci, Claudio
AU - Salvia, Roberto
AU - Sandström, Per
AU - Vissers, Frederique L. I. M.
AU - Wellner, Ulrich F.
AU - Zerbi, Alessandro
AU - Dijkgraaf, Marcel G. W.
AU - Besselink, Marc G.
AU - Abu Hilal, Mohammad
AU - European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS)
AU - Alseidi, Adnan
AU - Aquilano, Constanza
AU - Arola, Johanna
AU - Bianchi, Denise
AU - Brown, Rachel
AU - Campani, Daniela
AU - ChinAleong, Joanne
AU - Cros, Jerome
AU - Dimitrova, Lyubomira
AU - Doglioni, Claudio
AU - Dokmak, Safi
AU - Dorer, Russell
AU - Verheij, Joanne
N1 - Funding Information: Medtronic Covidien AG, Johnson & Johnson Medical Limited, Dutch Gastroenterology Society.Tobias Keck is a member of the advisory board for Olympus, Medtronic, and Dexter. Daan Lips received a proctoring grant by Intuitive Surgical. Marc Besselink and Mohammad Abu Hilal received Investigator Initiated Research grants by Medtronic (DIPLOMA trial), Ethicon (DIPLOMA trial and E-MIPS registry), and Intuitive Surgical (E-MIPS registry) and proctoring grants for Dutch and European training programs in robotic pancreatoduodenectomy by Intuitive Surgical. The other authors have no conflicts of interest. Publisher Copyright: © 2023 The Authors
PY - 2023/8/1
Y1 - 2023/8/1
N2 - Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods: In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of −7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI −6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0–30.0] vs 23.0 [14.0–32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0–30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5–5.5] vs 5 [95% CI 4.7–5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67–1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation: This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding: Medtronic Covidien AG, Johnson & Johnson Medical Limited, Dutch Gastroenterology Society.
AB - Background: The oncological safety of minimally invasive surgery has been questioned for several abdominal cancers. Concerns also exist regarding the use of minimally invasive distal pancreatectomy (MIDP) in patients with resectable pancreatic cancer as randomised trials are lacking. Methods: In this international randomised non-inferiority trial, we recruited adults with resectable pancreatic cancer from 35 centres in 12 countries. Patients were randomly assigned to either MIDP (laparoscopic or robotic) or open distal pancreatectomy (ODP). Both patients and pathologists were blinded to the assigned approach. Primary endpoint was radical resection (R0, ≥1 mm free margin) in patients who had ultimately undergone resection. Analyses for the primary endpoint were by modified intention-to-treat, excluding patients with missing data on primary endpoint. The pre-defined non-inferiority margin of −7% was compared with the lower limit of the two-sided 90% confidence interval (CI) of absolute difference in the primary endpoint. This trial is registered with the ISRCTN registry (ISRCTN44897265). Findings: Between May 8, 2018 and May 7, 2021, 258 patients were randomly assigned to MIDP (131 patients) or ODP (127 patients). Modified intention-to-treat analysis included 114 patients in the MIDP group and 110 patients in the ODP group. An R0 resection occurred in 83 (73%) patients in the MIDP group and in 76 (69%) patients in the ODP group (difference 3.7%, 90% CI −6.2 to 13.6%; pnon-inferiority = 0.039). Median lymph node yield was comparable (22.0 [16.0–30.0] vs 23.0 [14.0–32.0] nodes, p = 0.86), as was the rate of intraperitoneal recurrence (41% vs 38%, p = 0.45). Median follow-up was 23.5 (interquartile range 17.0–30.0) months. Other postoperative outcomes were comparable, including median time to functional recovery (5 [95% CI 4.5–5.5] vs 5 [95% CI 4.7–5.3] days; p = 0.22) and overall survival (HR 0.99, 95% CI 0.67–1.46, p = 0.94). Serious adverse events were reported in 23 (18%) of 131 patients in the MIDP group vs 28 (22%) of 127 patients in the ODP group. Interpretation: This trial provides evidence on the non-inferiority of MIDP compared to ODP regarding radical resection rates in patients with resectable pancreatic cancer. The present findings support the applicability of minimally invasive surgery in patients with resectable left-sided pancreatic cancer. Funding: Medtronic Covidien AG, Johnson & Johnson Medical Limited, Dutch Gastroenterology Society.
KW - Distal pancreatectomy
KW - Minimally invasive surgery
KW - Pancreatic ductal adenocarcinoma
UR - http://www.scopus.com/inward/record.url?scp=85164340899&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.lanepe.2023.100673
DO - https://doi.org/10.1016/j.lanepe.2023.100673
M3 - Article
C2 - 37457332
SN - 2666-7762
VL - 31
SP - 100673
JO - The Lancet Regional Health - Europe
JF - The Lancet Regional Health - Europe
M1 - 100673
ER -