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Minimally invasive versus open distal pancreatectomy for resectable pancreatic cancer (DIPLOMA): an international randomised non-inferiority trial
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- Korrel, Maarten (författare)
- Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands
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- Jones, Leia R. (författare)
- Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands
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- van Hilst, Jony (författare)
- Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands; OLVG Hosp, Netherlands
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- Balzano, Gianpaolo (författare)
- Univ Vita Salute, Italy
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- Björnsson, Bergthor, 1975- (författare)
- Linköpings universitet,Medicinska fakulteten,Avdelningen för kirurgi, ortopedi och onkologi,Region Östergötland, Kirurgiska kliniken US
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- Boggi, Ugo (författare)
- Univ Pisa, Italy
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- Bratlie, Svein Olav (författare)
- Sahlgrens Univ Hosp, Sweden
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- Busch, Olivier R. (författare)
- Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands
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- Butturini, Giovanni (författare)
- Pederzoli Hosp, Italy
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- Capretti, Giovanni (författare)
- Humanitas Univ, Italy; IRCCS Humanitas Res Hosp, Italy
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- Casadei, Riccardo (författare)
- Univ Bologna, Italy
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- Edwin, Bjorn (författare)
- Univ Oslo, Norway; Univ Oslo, Norway
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- Emmen, Anouk M. L. H. (författare)
- Ist Osped Fdn Poliambulanza, Italy; Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands
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- Esposito, Alessandro (författare)
- Univ Hosp Verona, Italy
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- Falconi, Massimo (författare)
- Univ Vita Salute, Italy
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- Koerkamp, Bas Groot (författare)
- Erasmus MC Canc Inst, Netherlands
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- Keck, Tobias (författare)
- Dept Surg, Germany
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- de Kleine, Ruben H. J. (författare)
- Univ Med Ctr Groningen, Netherlands
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- Kleive, Dyre B. (författare)
- Natl Hosp Norway, Norway
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- Kokkola, Arto (författare)
- Helsinki Univ Hosp, Finland
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- Lips, Daan J. (författare)
- Med Spectrum Twente, Netherlands
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- Lof, Sanne (författare)
- Univ Amsterdam, Netherlands; Univ Hosp Southampton NHS Fdn Trust, England
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- Luyer, Misha D. P. (författare)
- Catharina Hosp, Netherlands
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- Manzoni, Alberto (författare)
- Ist Osped Fdn Poliambulanza, Italy
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- Marudanayagam, Ravi (författare)
- Univ Hosp Birmingham, England
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- de Pastena, Matteo (författare)
- Univ Hosp Verona, Italy
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- Pecorelli, Nicolo (författare)
- Univ Vita Salute, Italy
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- Primrose, John N. (författare)
- Univ Hosp Southampton NHS Fdn Trust, England
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- Ricci, Claudio (författare)
- Univ Bologna, Italy
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- Salvia, Roberto (författare)
- Univ Hosp Verona, Italy
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- Sandström, Per (författare)
- Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,Region Östergötland, Kirurgiska kliniken US
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- Vissers, Frederique L. I. M. (författare)
- Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands
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- Wellner, Ulrich F. (författare)
- Dept Surg, Germany
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- Zerbi, Alessandro (författare)
- Humanitas Univ, Italy; IRCCS Humanitas Res Hosp, Italy
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- Dijkgraaf, Marcel G. W. (författare)
- Univ Amsterdam, Netherlands; Amsterdam Publ Hlth, Netherlands
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- Besselink, Marc G. (författare)
- Univ Amsterdam, Netherlands; Canc Ctr Amsterdam, Netherlands
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- Abu Hilal, Mohammad (författare)
- Ist Osped Fdn Poliambulanza, Italy; Univ Hosp Southampton NHS Fdn Trust, England
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(creator_code:org_t)
- ELSEVIER, 2023
- 2023
- Engelska.
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Ingår i: The Lancet Regional Health. - : ELSEVIER. - 2666-7762. ; 31
- Relaterad länk:
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https://liu.diva-por... (primary) (Raw object)
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Nyckelord
- Distal pancreatectomy; Pancreatic ductal adenocarcinoma; Minimally invasive surgery
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Korrel, Maarten
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Jones, Leia R.
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van Hilst, Jony
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Balzano, Gianpao ...
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Björnsson, Bergt ...
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Boggi, Ugo
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visa fler...
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Bratlie, Svein O ...
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Busch, Olivier R ...
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Butturini, Giova ...
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Capretti, Giovan ...
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Casadei, Riccard ...
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Edwin, Bjorn
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Emmen, Anouk M. ...
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Esposito, Alessa ...
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Falconi, Massimo
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Koerkamp, Bas Gr ...
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Keck, Tobias
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de Kleine, Ruben ...
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Kleive, Dyre B.
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Kokkola, Arto
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Lips, Daan J.
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Lof, Sanne
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Luyer, Misha D. ...
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Manzoni, Alberto
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Marudanayagam, R ...
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de Pastena, Matt ...
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Pecorelli, Nicol ...
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Primrose, John N ...
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Ricci, Claudio
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Salvia, Roberto
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Sandström, Per
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Vissers, Frederi ...
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Wellner, Ulrich ...
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Zerbi, Alessandr ...
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Dijkgraaf, Marce ...
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Besselink, Marc ...
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Abu Hilal, Moham ...
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