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  • Korrel, MaartenIst Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands (författare)

Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial

  • Artikel/kapitelEngelska2023

Förlag, utgivningsår, omfång ...

  • ELSEVIER,2023
  • electronicrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:liu-198254
  • https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-198254URI
  • https://doi.org/10.1016/j.lanepe.2023.100673DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Funding Agencies|Medtronic Covidien AG; Johnson amp; Johnson Medical Limited; Dutch Gastroenterology Society
  • 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, & GE;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. Copyright & COPY; 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Jones, Leia R.Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands (författare)
  • van Hilst, JonyUniv Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands; OLVG Hosp, Netherlands (författare)
  • Balzano, GianpaoloUniv Vita Salute, Italy (författare)
  • Björnsson, Bergthor,1975-Linköpings universitet,Medicinska fakulteten,Avdelningen för kirurgi, ortopedi och onkologi,Region Östergötland, Kirurgiska kliniken US(Swepub:liu)berbj34 (författare)
  • Boggi, UgoUniv Pisa, Italy (författare)
  • Bratlie, Svein OlavSahlgrens Univ Hosp, Sweden (författare)
  • Busch, Olivier R.Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands (författare)
  • Butturini, GiovanniPederzoli Hosp, Italy (författare)
  • Capretti, GiovanniHumanitas Univ, Italy; IRCCS Humanitas Res Hosp, Italy (författare)
  • Casadei, RiccardoUniv Bologna, Italy (författare)
  • Edwin, BjornUniv Oslo, Norway; Univ Oslo, Norway (författare)
  • Emmen, Anouk M. L. H.Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands (författare)
  • Esposito, AlessandroUniv Hosp Verona, Italy (författare)
  • Falconi, MassimoUniv Vita Salute, Italy (författare)
  • Koerkamp, Bas GrootErasmus MC Canc Inst, Netherlands (författare)
  • Keck, TobiasDept Surg, Germany (författare)
  • de Kleine, Ruben H. J.Univ Med Ctr Groningen, Netherlands (författare)
  • Kleive, Dyre B.Natl Hosp Norway, Norway (författare)
  • Kokkola, ArtoHelsinki Univ Hosp, Finland (författare)
  • Lips, Daan J.Med Spectrum Twente, Netherlands (författare)
  • Lof, SanneUniv Amsterdam, Netherlands; Univ Hosp Southampton NHS Fdn Trust, England (författare)
  • Luyer, Misha D. P.Catharina Hosp, Netherlands (författare)
  • Manzoni, AlbertoIst Osped Fdn Poliambulanza, Italy (författare)
  • Marudanayagam, RaviUniv Hosp Birmingham, England (författare)
  • de Pastena, MatteoUniv Hosp Verona, Italy (författare)
  • Pecorelli, NicoloUniv Vita Salute, Italy (författare)
  • Primrose, John N.Univ Hosp Southampton NHS Fdn Trust, England (författare)
  • Ricci, ClaudioUniv Bologna, Italy (författare)
  • Salvia, RobertoUniv Hosp Verona, Italy (författare)
  • Sandström, PerLinköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken US(Swepub:liu)persa07 (författare)
  • Vissers, Frederique L. I. M.Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands (författare)
  • Wellner, Ulrich F.Dept Surg, Germany (författare)
  • Zerbi, AlessandroHumanitas Univ, Italy; IRCCS Humanitas Res Hosp, Italy (författare)
  • Dijkgraaf, Marcel G. W.Univ Amsterdam, Netherlands; Amsterdam Publ Hlth, Netherlands (författare)
  • Besselink, Marc G.Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands (författare)
  • Abu Hilal, MohammadIst Osped Fdn Poliambulanza, Italy; Univ Hosp Southampton NHS Fdn Trust, England (författare)
  • Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, NetherlandsUniv Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands; OLVG Hosp, Netherlands (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:The Lancet Regional Health: ELSEVIER312666-7762

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