Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA) – a randomized controlled trial
Rationale: Several systematic reviews have suggested superior outcomes after minimally invasive distal pancreatectomy (MIDP) as compared to open distal pancreatectomy (ODP) for benign and pre-malignant disease. In the literature and in a recent pan-European survey, about one third of pancreatic surgeons expressed concerns specifically regarding the oncologic safety (i.e. radical resection, lymph node retrieval and survival) of MIDP in pancreatic cancer. Most surgeons stated that a randomised trial assessing oncologic safety in MIDP vs ODP for pancreatic cancer is needed.
Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.
Study design: A pan-European, randomised controlled, multicentre, patient-blinded non-inferiority trial. The protocol was designed according to the SPIRIT guidelines1.
Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC.
Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted)
Control: Open distal pancreatectomy
Main study parameters/endpoints: Primary outcome is the microscopically radical (R0, >1mm) resection rate. Main secondary outcomes are lymph node retrieval, intraoperative outcomes (such as blood loss, operative time and conversion), postoperative outcomes (such as complications and hospitalisation parameters), quality of life and survival. Patients are stratified per centre
Maarten Korrel, MD-PhD candidate
Academic Medical Centre, Amsterdam
Department of Surgery
PO Box 22660
1100 DD Amsterdam
Tel: +31 6 57 02 84 13
Sanne Lof, MD, PhD candidate
University Hospital Southampton NHS FT
Department of Surgery
Tremona Road, Southampton, SO16 2YD, UK
Tel: +44 74 8323 6361
4th DIPLOMA TRIAL MEETING AT SCHIPHOL AIRPORT 6 April 2018
Thanks all for a productive final preparatory meeting; We are now ready for study inclusion!
CONGRATULATIONS TO ALL E-MIPS MEMBERS FOR THE FIRST CONSORTIUM PUBLICATION!
Ann Surg. 2017 Nov 2. [Epub ahead of print] PMID: 29099399 DOI: 10.1097/SLA.0000000000002561