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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00007885naa a2200949 4500
001oai:DiVA.org:liu-179606
003SwePub
008210928s2021 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-1796062 URI
0247 a https://doi.org/10.1186/s13063-021-05506-z2 DOI
040 a (SwePub)liu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a van Hilst, Jonyu Univ Amsterdam, Netherlands4 aut
2451 0a Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA) :b study protocol for a randomized controlled trial
264 c 2021-09-09
264 1b BMC,c 2021
338 a electronic2 rdacarrier
500 a Funding Agencies|Covidien AG (Medtronic, Neuhausen am Rheinfall, Switzerland) [ISR2017-10928]
520 a Background: Recently, the first randomized trials comparing minimally invasive distal pancreatectomy (MIDP) with open distal pancreatectomy (ODP) for non-malignant and malignant disease showed a 2-day reduction in time to functional recovery after MIDP. However, for pancreatic ductal adenocarcinoma (PDAC), concerns have been raised regarding the oncologic safety (i.e., radical resection, lymph node retrieval, and survival) of MIDP, as compared to ODP. Therefore, a randomized controlled trial comparing MIDP and ODP in PDAC regarding oncological safety is warranted. We hypothesize that the microscopically radical resection (R0) rate is non-inferior for MIDP, as compared to ODP. Methods/design: DIPLOMA is an international randomized controlled, patient- and pathologist-blinded, non-inferiority trial performed in 38 pancreatic centers in Europe and the USA. A total of 258 patients with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC of the pancreatic body or tail will be randomly allocated to MIDP (laparoscopic or robot-assisted) or ODP in a 1:1 ratio. The primary outcome is the microscopically radical resection margin (R0, distance tumor to pancreatic transection and posterior margin >= 1 mm), which is assessed using a standardized histopathology assessment protocol. The sample size is calculated with the following assumptions: 5% one-sided significance level (alpha), 80% power (1-beta), expected R0 rate in the open group of 58%, expected R0 resection rate in the minimally invasive group of 67%, and a non-inferiority margin of 7%. Secondary outcomes include time to functional recovery, operative outcomes (e.g., blood loss, operative time, and conversion to open surgery), other histopathology findings (e.g., lymph node retrieval, perineural- and lymphovascular invasion), postoperative outcomes (e.g., clinically relevant complications, hospital stay, and administration of adjuvant treatment), time and site of disease recurrence, survival, quality of life, and costs. Follow-up will be performed at the outpatient clinic after 6, 12, 18, 24, and 36 months postoperatively. Discussion: The DIPLOMA trial is designed to investigate the non-inferiority of MIDP versus ODP regarding the microscopically radical resection rate of PDAC in an international setting.
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 Minimally invasive; Laparoscopic; Robot-assisted; Distal pancreatectomy; Left pancreatectomy; Pancreatic tail resection; Pancreatic surgery; Pancreatic cancer; Pancreatic ductal adenocarcinoma
7001 a Korrel, Maartenu Univ Amsterdam, Netherlands4 aut
7001 a Lof, Sanneu Univ Amsterdam, Netherlands; Inst Osped Fdn Poliambulanza, Italy4 aut
7001 a de Rooij, Thijsu Univ Amsterdam, Netherlands4 aut
7001 a Vissers, Frederiqueu Univ Amsterdam, Netherlands4 aut
7001 a Al-Sarireh, Bilalu Morriston Hosp, Wales4 aut
7001 a Alseidi, Adnanu Virginia Mason Med Ctr, WA 98101 USA4 aut
7001 a Bateman, Adrian C.u Univ Hosp Southampton NHS Fdn Trust, England4 aut
7001 a Björnsson, Bergthoru Linköpings universitet,Avdelningen för kirurgi, ortopedi och onkologi,Medicinska fakulteten,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, Olivieru Univ Amsterdam, Netherlands4 aut
7001 a Butturini, Giovanniu Pederzoli Hosp, Italy4 aut
7001 a Casadei, Riccardou Univ Bologna, Italy4 aut
7001 a Dijk, Frederikeu Amsterdam UMC, Netherlands4 aut
7001 a Dokmak, Safiu Beaujon Hosp, France4 aut
7001 a Edwin, Bjornu Oslo Univ Hosp, Norway; Inst Clin Med, Norway4 aut
7001 a van Eijck, Casperu Erasmus MC Canc Inst, Netherlands4 aut
7001 a Esposito, Alessandrou Univ Hosp Verona, Italy4 aut
7001 a Fabre, Jean-Michelu Hop St Eloi, France4 aut
7001 a Falconi, Massimou Univ Vita Salute, Italy4 aut
7001 a Ferrari, Giovanniu Osped Niguarda Ca Granda, Italy4 aut
7001 a Fuks, Davidu Inst Mutualiste Montsouris, France4 aut
7001 a Koerkamp, Bas Grootu Erasmus MC Canc Inst, Netherlands4 aut
7001 a Hackert, Thilou Heidelberg Univ Hosp, Germany4 aut
7001 a Keck, Tobiasu Dept Surg, Germany4 aut
7001 a Khatkov, Igoru Moscow Clin Sci Ctr, Russia4 aut
7001 a de Kleine, Rubenu Univ Med Ctr Groningen, Netherlands4 aut
7001 a Kokkola, Artou Univ Helsinki, Finland; Helsinki Univ Hosp, Finland4 aut
7001 a Kooby, David A.u Emory Univ Hosp, GA 30322 USA4 aut
7001 a Lips, Daanu Med Spectrum Twente, Netherlands4 aut
7001 a Luyer, Mishau Catharina Hosp, Netherlands4 aut
7001 a Marudanayagam, Raviu Univ Hosp Birmingham, England4 aut
7001 a Menon, Krishnau Kings Coll Hosp NHS Fdn Trust, England4 aut
7001 a Molenaar, Quintusu Univ Med Ctr Utrecht, Netherlands4 aut
7001 a de Pastena, Matteou Univ Hosp Verona, Italy4 aut
7001 a Pietrabissa, Andreau IRCCS Policlin San Matteo Pavia, Italy4 aut
7001 a Rajak, Rushdau Virginia Mason Med Ctr, WA 98101 USA4 aut
7001 a Rosso, Edoardou Inst Osped Fdn Poliambulanza, Italy4 aut
7001 a Sanchez Velazquez, Patriciau Hosp del Mar, Spain4 aut
7001 a Saint Marc, Olivieru Ctr Hosp Reg Orleans, France4 aut
7001 a Shah, Mihiru Emory Univ Hosp, GA 30322 USA4 aut
7001 a Soonawalla, Zahiru Oxford Univ Hosp NHS Fdn Trust, England4 aut
7001 a Tomazic, Alesu Univ Med Ctr Ljubljana, Slovenia4 aut
7001 a Verbeke, Carolineu Univ Oslo, Norway4 aut
7001 a Verheij, Joanneu Amsterdam UMC, Netherlands4 aut
7001 a White, Stevenu Freeman Hosp Newcastle Upon Tyne, England4 aut
7001 a Wilmink, Hanneke W.u Amsterdam UMC, Netherlands4 aut
7001 a Zerbi, Alessandrou IRCCS, Italy; Humanitas Univ, Italy4 aut
7001 a Dijkgraaf, Marcel G.u Univ Amsterdam, Netherlands4 aut
7001 a Besselink, Marc G.u Univ Amsterdam, Netherlands4 aut
7001 a Abu Hilal, Mohammadu Inst Osped Fdn Poliambulanza, Italy; Fdn Poliambulanza Inst Osped, Italy4 aut
7102 a Univ Amsterdam, Netherlandsb Univ Amsterdam, Netherlands; Inst Osped Fdn Poliambulanza, Italy4 org
7730 t Trialsd : BMCg 22:1q 22:1x 1745-6215
8564 u https://liu.diva-portal.org/smash/get/diva2:1598000/FULLTEXT01.pdfx primaryx Raw objecty fulltext:print
8564 u https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-021-05506-z
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-179606
8564 8u https://doi.org/10.1186/s13063-021-05506-z

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