TY - JOUR
T1 - Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA)
T2 - study protocol for a randomized controlled trial
AU - European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS)
AU - van Hilst, Jony
AU - Korrel, Maarten
AU - Lof, Sanne
AU - de Rooij, Thijs
AU - Vissers, Frederique
AU - Al-Sarireh, Bilal
AU - Alseidi, Adnan
AU - Bateman, Adrian C
AU - Björnsson, Bergthor
AU - Boggi, Ugo
AU - Bratlie, Svein Olav
AU - Busch, Olivier
AU - Butturini, Giovanni
AU - Casadei, Riccardo
AU - Dijk, Frederike
AU - Dokmak, Safi
AU - Edwin, Bjorn
AU - van Eijck, Casper
AU - Esposito, Alessandro
AU - Fabre, Jean-Michel
AU - Falconi, Massimo
AU - Ferrari, Giovanni
AU - Fuks, David
AU - Groot Koerkamp, Bas
AU - Hackert, Thilo
AU - Keck, Tobias
AU - Khatkov, Igor
AU - de Kleine, Ruben
AU - Kokkola, Arto
AU - Kooby, David A
AU - Lips, Daan
AU - Luyer, Misha
AU - Marudanayagam, Ravi
AU - Menon, Krishna
AU - Molenaar, Quintus
AU - de Pastena, Matteo
AU - Pietrabissa, Andrea
AU - Rajak, Rushda
AU - Rosso, Edoardo
AU - Sanchez Velazquez, Patricia
AU - Saint Marc, Olivier
AU - Shah, Mihir
AU - Soonawalla, Zahir
AU - Tomazic, Ales
AU - Verbeke, Caroline
AU - Verheij, Joanne
AU - White, Steven
AU - Wilmink, Hanneke W
AU - Zerbi, Alessandro
AU - Dijkgraaf, Marcel G
N1 - © 2021. The Author(s).
PY - 2021/9/9
Y1 - 2021/9/9
N2 - 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 (α), 80% power (1-β), 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.TRIAL REGISTRATION: ISRCTN registry ISRCTN44897265 . Prospectively registered on 16 April 2018.
AB - 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 (α), 80% power (1-β), 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.TRIAL REGISTRATION: ISRCTN registry ISRCTN44897265 . Prospectively registered on 16 April 2018.
U2 - 10.1186/s13063-021-05506-z
DO - 10.1186/s13063-021-05506-z
M3 - Journal articles
C2 - 34503548
SN - 1745-6215
VL - 22
SP - 608
JO - Trials
JF - Trials
IS - 1
ER -