DIPLOMA RCT2019-02-22T09:19:38+01:00

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, 23 patients from 13 centers in The Netherlands, United Kingdom, the United States, Italy, Norway and Finland have been randomized.

Enrolling centers, including their local Principal Investigators, are:

Center Principal Investigator No. of inclusions
Amsterdam UMC, location AMC, Amsterdam, the Netherlands Prof. Marc Besselink 5
University Hospital Southampton, Southampton, United Kingdom Prof. Mohammad Abu Hilal 3
Erasmus Medical Center, Rotterdam, the Netherlands Dr. Bas Groot Koerkamp 2
Virginia Mason Medical Center, Seattle, USA Dr. Adnan Alseidi 2

University Hospital Oslo, Oslo, Norway

Prof. Bjorn Edwin

2

Verona University Hospital, Verona, Italy

Dr. Alessandro Esposito

2
Humanitas University Hospital, Milan, Italy Prof. Alessandro Zerbi 1
Catharina Hospital, Eindhoven, the Netherlands Dr. Misha Luyer 1
University Hospital Birmingham, Birmingham, United Kingdom Dr. Ravi Marudanayagam
Pederzoli Hospital, Peschiera, Italy Prof. Giovanni Butturini 1
University Medical Center Ljubljana, Slovenia Prof. Ales Tomazic 1
Helsinki University Hospital, Helsinki, Finland  dr. Arto Kokkola 1
Fondazione Poliambulanza Istituto Ospedaliero, Brescia, Italy  dr. Edoardo Rosso 1
     
Total  

22

 

Enrollment rate

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Endorsed by:

Swedish Study Group
for Pancreatic Cancer
(SSPAC)