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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00007621naa a2200745 4500
001oai:DiVA.org:liu-198254
003SwePub
008231003s2023 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-1982542 URI
0247 a https://doi.org/10.1016/j.lanepe.2023.1006732 DOI
040 a (SwePub)liu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Korrel, Maartenu Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands4 aut
2451 0a Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial
264 1b ELSEVIER,c 2023
338 a electronic2 rdacarrier
500 a Funding Agencies|Medtronic Covidien AG; Johnson amp; Johnson Medical Limited; Dutch Gastroenterology Society
520 a 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/).
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Kirurgi0 (SwePub)302122 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Surgery0 (SwePub)302122 hsv//eng
653 a Distal pancreatectomy; Pancreatic ductal adenocarcinoma; Minimally invasive surgery
7001 a Jones, Leia R.u Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands4 aut
7001 a van Hilst, Jonyu Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands; OLVG Hosp, Netherlands4 aut
7001 a Balzano, Gianpaolou Univ Vita Salute, Italy4 aut
7001 a Björnsson, Bergthor,d 1975-u Linköpings universitet,Medicinska fakulteten,Avdelningen för kirurgi, ortopedi och onkologi,Region Östergötland, Kirurgiska kliniken US4 aut0 (Swepub:liu)berbj34
7001 a Boggi, Ugou Univ Pisa, Italy4 aut
7001 a Bratlie, Svein Olavu Sahlgrens Univ Hosp, Sweden4 aut
7001 a Busch, Olivier R.u Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands4 aut
7001 a Butturini, Giovanniu Pederzoli Hosp, Italy4 aut
7001 a Capretti, Giovanniu Humanitas Univ, Italy; IRCCS Humanitas Res Hosp, Italy4 aut
7001 a Casadei, Riccardou Univ Bologna, Italy4 aut
7001 a Edwin, Bjornu Univ Oslo, Norway; Univ Oslo, Norway4 aut
7001 a Emmen, Anouk M. L. H.u Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands4 aut
7001 a Esposito, Alessandrou Univ Hosp Verona, Italy4 aut
7001 a Falconi, Massimou Univ Vita Salute, Italy4 aut
7001 a Koerkamp, Bas Grootu Erasmus MC Canc Inst, Netherlands4 aut
7001 a Keck, Tobiasu Dept Surg, Germany4 aut
7001 a de Kleine, Ruben H. J.u Univ Med Ctr Groningen, Netherlands4 aut
7001 a Kleive, Dyre B.u Natl Hosp Norway, Norway4 aut
7001 a Kokkola, Artou Helsinki Univ Hosp, Finland4 aut
7001 a Lips, Daan J.u Med Spectrum Twente, Netherlands4 aut
7001 a Lof, Sanneu Univ Amsterdam, Netherlands; Univ Hosp Southampton NHS Fdn Trust, England4 aut
7001 a Luyer, Misha D. P.u Catharina Hosp, Netherlands4 aut
7001 a Manzoni, Albertou Ist Osped Fdn Poliambulanza, Italy4 aut
7001 a Marudanayagam, Raviu Univ Hosp Birmingham, England4 aut
7001 a de Pastena, Matteou Univ Hosp Verona, Italy4 aut
7001 a Pecorelli, Nicolou Univ Vita Salute, Italy4 aut
7001 a Primrose, John N.u Univ Hosp Southampton NHS Fdn Trust, England4 aut
7001 a Ricci, Claudiou Univ Bologna, Italy4 aut
7001 a Salvia, Robertou Univ Hosp Verona, Italy4 aut
7001 a Sandström, Peru Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken US4 aut0 (Swepub:liu)persa07
7001 a Vissers, Frederique L. I. M.u Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands4 aut
7001 a Wellner, Ulrich F.u Dept Surg, Germany4 aut
7001 a Zerbi, Alessandrou Humanitas Univ, Italy; IRCCS Humanitas Res Hosp, Italy4 aut
7001 a Dijkgraaf, Marcel G. W.u Univ Amsterdam, Netherlands; Amsterdam Publ Hlth, Netherlands4 aut
7001 a Besselink, Marc G.u Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands4 aut
7001 a Abu Hilal, Mohammadu Ist Osped Fdn Poliambulanza, Italy; Univ Hosp Southampton NHS Fdn Trust, England4 aut
7102 a Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlandsb Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands; OLVG Hosp, Netherlands4 org
7730 t The Lancet Regional Healthd : ELSEVIERg 31q 31x 2666-7762
8564 u https://liu.diva-portal.org/smash/get/diva2:1801886/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-198254
8564 8u https://doi.org/10.1016/j.lanepe.2023.100673

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