DIPLOMA RCT2019-04-26T15:05:32+02:00

Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA) – a randomized controlled trial

PROTOCOL SUMMARY:

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 center

STUDY COORDINATORS:

Frederique Vissers, MD, PhD candidate
Amsterdam University Medical Centers, Location AMC
Department of Surgery
PO Box 22660
1100 DD Amsterdam
Tel: +31 6 15 21 31 94

Sanne Lof, MD, PhD candidate
University Hospital Southampton NHS FT
Department of Surgery
Tremona Road, Southampton, SO16 2YD, UK
Tel: +44 74 8323 6361

Maarten Korrel, MD-PhD candidate
Amsterdam University Medical Centers, Location AMC
Department of Surgery
PO Box 22660
1100 DD Amsterdam
Tel: +31 6 15 21 31 94

Contact

 

CURRENT ENROLLMENT

Currently, 39 patients from 18 centers in The Netherlands, United Kingdom, United States, Italy, Norway, Finland, Slovenia and Spain have been randomized.

Enrolling centers, including their local Principal Investigators and pathologist, are:

Center Principal Investigator Pathologist 
Amsterdam UMC, location AMC, Amsterdam, the Netherlands Prof. Marc Besselink  Dr. J. Verheij
University Hospital Southampton, Southampton, United Kingdom Prof. Mohammad Abu Hilal Dr. Rusha Rajak
Erasmus Medical Center, Rotterdam, the Netherlands Dr. Bas Groot Koerkamp Dr. M. Doukas
Virginia Mason Medical Center, Seattle, USA Dr. Adnan Alseidi Dr. R. Dorer
University Hospital Oslo, Oslo, Norway Prof. Bjorn Edwin Dr. C. Verbeke
Verona University Hospital, Verona, Italy Dr. Alessandro Esposito Prof. A. Scarpa
Humanitas University Hospital, Milan, Italy Prof. Alessandro Zerbi Dr. P. Spaggiari
Catharina Hospital, Eindhoven, the Netherlands Dr. Misha Luyer Dr. C. Huijsentruijt
University Hospital Birmingham, Birmingham, United Kingdom Dr. Ravi Marudanayagam Dr. R. Brown
Pederzoli Hospital, Peschiera, Italy Prof. Giovanni Butturini Dr S. Gobbo
University Medical Center Ljubljana, Slovenia Prof. Ales Tomazic Dr. B.  Ranković
Helsinki University Hospital, Helsinki, Finland  Dr. Arto Kokkola Dr. J. Arola
Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy  Dr. Edoardo Rosso  Dr. Fausto Zorzi
Hospital del Mar, Barcelona, Spain Prof. Ignasi Poves Dr. M. Iglesias Coma
San Raffaele Hospital IRCCS, Milan, Italy Prof. Massimo Falconi prof. C. Doglioni
IRCCS Policlinico San Matteo, Pavia, Italy Prof. Andrea Pietrabissa Dr. A. Vanoli
S. Orsola-Malpighi Hospital, Bologna, Italy  Prof. Riccardo Casadei Dr. D. Santini
Oxford University Hospital, Oxford, United Kingdom Dr. Zahir Soonawalla Dr Aniko Rendek
Total inclusions  

39

 

Enrollment rate

News:

5th DIPLOMA/E-MIPS Meeting at IHPBA, Geneva

We would like to thank all attendees for a very productive meeting on Thursday morning during the 2018 IHPBA congress in Geneva. Please find the minutes here: 5th DIPLOMA E-MIPS meeting IHPBA Geneva. E-AHPBA E-MIPS Registry [...]

September 6th, 2018|Comments Off on 5th DIPLOMA/E-MIPS Meeting at IHPBA, Geneva
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Events:

Endorsed by:

Swedish Study Group
for Pancreatic Cancer
(SSPAC)