| Title: |
Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial |
| Authors: |
Korrel M.; Jones L. R.; van Hilst J.; Balzano G.; Bjornsson B.; Boggi U.; Bratlie S. O.; Busch O. R.; Butturini G.; Capretti G.; Casadei R.; Edwin B.; Emmen A. M. L. H.; Esposito A.; Falconi M.; Groot Koerkamp B.; Keck T.; de Kleine R. H. J.; Kleive D. B.; Kokkola A.; Lips D. J.; Lof S.; Luyer M. D. P.; Manzoni A.; Marudanayagam R.; de Pastena M.; Pecorelli N.; Primrose J. N.; Ricci C.; Salvia R.; Sandstrom P.; Vissers F. L. I. M.; Wellner U. F.; Zerbi A.; Dijkgraaf M. G. W.; Besselink M. G.; Abu Hilal M.; Alseidi A.; Aquilano C.; Arola J.; Bianchi D.; Brown R.; Campani D.; ChinAleong J.; Cros J.; Dimitrova L.; Doglioni C.; Dokmak S.; Dorer R.; Doukas M.; Fabre J. M.; Ferrari G.; Grinevich V.; Gobbo S.; Hackert T.; van den Heuvel M.; Huijsentruijt C.; Iglesias M.; Jansen C.; Khatkov I.; Kooby D.; Lena M.; Luchini C.; Menon K.; Michenet P.; Molenaar Q.; Nedkova A.; Pietrabissa A.; Raicu M.; Rajak R.; Rankovic B.; Rendek A.; Riviere B.; Cunha A. S.; Marc O. S.; Velazquez P. S.; Santini D.; Scarpa A.; Sebagh M.; Sears D.; Shah M.; Soonawalla Z.; Spaggiari P.; Tharun L.; Tholfsen T.; Tomazic A.; Vanoli A.; Verbeke C.; Verheij J.; Von Winterfeld M.; de Wilde R.; Yip V.; Zen Y. |
| Contributors: |
Korrel M.; Jones L.R.; van Hilst J.; Balzano G.; Bjornsson B.; Boggi U.; Bratlie S.O.; Busch O.R.; Butturini G.; Capretti G.; Casadei R.; Edwin B.; Emmen A.M.L.H.; Esposito A.; Falconi M.; Groot Koerkamp B.; Keck T.; de Kleine R.H.J.; Kleive D.B.; Kokkola A.; Lips D.J.; Lof S.; Luyer M.D.P.; Manzoni A.; Marudanayagam R.; de Pastena M.; Pecorelli N.; Primrose J.N.; Ricci C.; Salvia R.; Sandstrom P.; Vissers F.L.I.M.; Wellner U.F.; Zerbi A.; Dijkgraaf M.G.W.; Besselink M.G.; Abu Hilal M.; Alseidi A.; Aquilano C.; Arola J.; Bianchi D.; Brown R.; Campani D.; ChinAleong J.; Cros J.; Dimitrova L.; Doglioni C.; Dokmak S.; Dorer R.; Doukas M.; Fabre J.M.; Ferrari G.; Grinevich V.; Gobbo S.; Hackert T.; van den Heuvel M.; Huijsentruijt C.; Iglesias M.; Jansen C.; Khatkov I.; Kooby D.; Lena M.; Luchini C.; Menon K.; Michenet P.; Molenaar Q.; Nedkova A.; Pietrabissa A.; Raicu M.; Rajak R.; Rankovic B.; Rendek A.; Riviere B.; Cunha A.S.; Marc O.S.; Velazquez P.S.; Santini D.; Scarpa A.; Sebagh M.; Sears D.; Shah M.; Soonawalla Z.; Spaggiari P.; Tharun L.; Tholfsen T.; Tomazic A.; Vanoli A.; Verbeke C.; Verheij J.; Von Winterfeld M.; de Wilde R.; Yip V.; Zen Y. |
| Publication Year: |
2023 |
| Collection: |
IRIS Università degli Studi di Bologna (CRIS - Current Research Information System) |
| Subject Terms: |
Distal pancreatectomy; Minimally invasive surgery; Pancreatic ductal adenocarcinoma |
| Description: |
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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
ELETTRONICO |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/37457332; info:eu-repo/semantics/altIdentifier/wos/WOS:001059070400001; volume:31; firstpage:1; lastpage:15; numberofpages:15; journal:THE LANCET REGIONAL HEALTH. EUROPE; https://hdl.handle.net/11585/952185 |
| DOI: |
10.1016/j.lanepe.2023.100673 |
| Availability: |
https://hdl.handle.net/11585/952185; https://doi.org/10.1016/j.lanepe.2023.100673; https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(23)00092-3/fulltext |
| Rights: |
info:eu-repo/semantics/openAccess |
| Accession Number: |
edsbas.4190AE2F |
| Database: |
BASE |