Minimally invasive versus open distal pancreatectomy for pancreatic ductal adenocarcinoma (DIPLOMA): study protocol for a randomized controlled trial

Jony van Hilst*, Maarten Korrel, European Consortium on Minimally Invasive Pancreatic Surgery (E-MIPS), Sanne Lof, Thijs de Rooij, Frederique Vissers, Bilal Al-Sarireh, Adnan Alseidi, Adrian C Bateman, Bergthor Björnsson, Ugo Boggi, Svein Olav Bratlie, Olivier Busch, Giovanni Butturini, Riccardo Casadei, Frederike Dijk, Safi Dokmak, Bjorn Edwin, Casper van Eijck, Alessandro EspositoJean-Michel Fabre, Massimo Falconi, Giovanni Ferrari, David Fuks, Bas Groot Koerkamp, Thilo Hackert, Tobias Keck, Igor Khatkov, Ruben de Kleine, Arto Kokkola, David A Kooby, Daan Lips, Misha Luyer, Ravi Marudanayagam, Krishna Menon, Quintus Molenaar, Matteo de Pastena, Andrea Pietrabissa, Rushda Rajak, Edoardo Rosso, Patricia Sanchez Velazquez, Olivier Saint Marc, Mihir Shah, Zahir Soonawalla, Ales Tomazic, Caroline Verbeke, Joanne Verheij, Steven White, Hanneke W Wilmink, Alessandro Zerbi, Marcel G Dijkgraaf

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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Abstract

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.

Original languageEnglish
Article number608
JournalTrials
Volume22
Issue number1
DOIs
Publication statusPublished - 9 Sep 2021

Bibliographical note

Funding:
Covidien AG (Medtronic, Neuhausen am Rheinfall, Switzerland) financially
supported the investigator-initiated DIPLOMA trial (reference number ISR2017-10928). The funder had no influence on the DIPLOMA trial’s design and
will not have influence on data collection, interpretation of data, manuscript
development, or the decision to publish.

© 2021. The Author(s).

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