مورد إلكتروني
Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA) : study protocol for a randomized controlled trial
| العنوان: | Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA) : study protocol for a randomized controlled trial |
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| بيانات النشر: | Linköpings universitet, Avdelningen för kirurgi, ortopedi och onkologi Linköpings universitet, Medicinska fakulteten Region Östergötland, Kirurgiska kliniken US Univ Amsterdam, Netherlands Univ Amsterdam, Netherlands Univ Amsterdam, Netherlands; Inst Osped Fdn Poliambulanza, Italy Univ Amsterdam, Netherlands Univ Amsterdam, Netherlands Morriston Hosp, Wales Virginia Mason Med Ctr, WA 98101 USA Univ Hosp Southampton NHS Fdn Trust, England Univ Pisa, Italy Sahlgrens Univ Hosp, Sweden Univ Amsterdam, Netherlands Pederzoli Hosp, Italy Univ Bologna, Italy Amsterdam UMC, Netherlands Beaujon Hosp, France Oslo Univ Hosp, Norway; Inst Clin Med, Norway Erasmus MC Canc Inst, Netherlands Univ Hosp Verona, Italy Hop St Eloi, France Univ Vita Salute, Italy Osped Niguarda Ca Granda, Italy Inst Mutualiste Montsouris, France Erasmus MC Canc Inst, Netherlands Heidelberg Univ Hosp, Germany Dept Surg, Germany Moscow Clin Sci Ctr, Russia Univ Med Ctr Groningen, Netherlands Univ Helsinki, Finland; Helsinki Univ Hosp, Finland Emory Univ Hosp, GA 30322 USA Med Spectrum Twente, Netherlands Catharina Hosp, Netherlands Univ Hosp Birmingham, England Kings Coll Hosp NHS Fdn Trust, England Univ Med Ctr Utrecht, Netherlands Univ Hosp Verona, Italy IRCCS Policlin San Matteo Pavia, Italy Virginia Mason Med Ctr, WA 98101 USA Inst Osped Fdn Poliambulanza, Italy Hosp del Mar, Spain Ctr Hosp Reg Orleans, France Emory Univ Hosp, GA 30322 USA Oxford Univ Hosp NHS Fdn Trust, England Univ Med Ctr Ljubljana, Slovenia Univ Oslo, Norway Amsterdam UMC, Netherlands Freeman Hosp Newcastle Upon Tyne, England Amsterdam UMC, Netherlands IRCCS, Italy; Humanitas Univ, Italy Univ Amsterdam, Netherlands Univ Amsterdam, Netherlands Inst Osped Fdn Poliambulanza, Italy; Fdn Poliambulanza Inst Osped, Italy BMC 2021 |
| تفاصيل مُضافة: | van Hilst, Jony Korrel, Maarten Lof, Sanne de Rooij, Thijs Vissers, Frederique Al-Sarireh, Bilal Alseidi, Adnan Bateman, Adrian C. Björnsson, Bergthor Boggi, Ugo Bratlie, Svein Olav Busch, Olivier Butturini, Giovanni Casadei, Riccardo Dijk, Frederike Dokmak, Safi Edwin, Bjorn van Eijck, Casper Esposito, Alessandro Fabre, Jean-Michel Falconi, Massimo Ferrari, Giovanni Fuks, David Koerkamp, Bas Groot Hackert, Thilo Keck, Tobias Khatkov, Igor de Kleine, Ruben Kokkola, Arto Kooby, David A. Lips, Daan Luyer, Misha Marudanayagam, Ravi Menon, Krishna Molenaar, Quintus de Pastena, Matteo Pietrabissa, Andrea Rajak, Rushda Rosso, Edoardo Sanchez Velazquez, Patricia Saint Marc, Olivier Shah, Mihir Soonawalla, Zahir Tomazic, Ales Verbeke, Caroline Verheij, Joanne White, Steven Wilmink, Hanneke W. Zerbi, Alessandro Dijkgraaf, Marcel G. Besselink, Marc G. Abu Hilal, Mohammad |
| نوع الوثيقة: | Electronic Resource |
| مستخلص: | 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 si Funding Agencies|Covidien AG (Medtronic, Neuhausen am Rheinfall, Switzerland) [ISR2017-10928] |
| مصطلحات الفهرس: | Minimally invasive; Laparoscopic; Robot-assisted; Distal pancreatectomy; Left pancreatectomy; Pancreatic tail resection; Pancreatic surgery; Pancreatic cancer; Pancreatic ductal adenocarcinoma, Surgery, Kirurgi, Article in journal, info:eu-repo/semantics/article, text |
| DOI: | 10.1186.s13063-021-05506-z |
| URL: | Trials, 1745-6215, 2021, 22:1 |
| الإتاحة: | Open access content. Open access content info:eu-repo/semantics/openAccess |
| ملاحظة: | application/pdf English |
| أرقام أخرى: | UPE oai:DiVA.org:liu-179606 doi:10.1186/s13063-021-05506-z PMID 34503548 ISI:000694894400001 1280620073 |
| المصدر المساهم: | UPPSALA UNIV LIBR From OAIster®, provided by the OCLC Cooperative. |
| رقم الأكسشن: | edsoai.on1280620073 |
| قاعدة البيانات: | OAIster |
| DOI: | 10.1186.s13063-021-05506-z |
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