DIPLOMA RCT2019-07-29T10:40:41+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:

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

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

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

Contact

Enrollment rate

 

CURRENT ENROLLMENT

Currently, 54 patients from 20 centers in The Netherlands, United Kingdom, United States, Italy, Norway, Finland, Slovenia, Spain and Germany 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
Lübeck University Hospital, Lübeck, Germany Prof. Tobias Keck Dr. Lars Tharun
King’s College Hospital, London, UK Dr. Krishna Menon Dr. Zen
Total inclusions  

65

 

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:

E-AHPBA/E-MIPS REGISTRY

1 June 2019 @ 08:00 - 1 June 2021 @ 17:00 CEST

Endorsed by:

Swedish Study Group
for Pancreatic Cancer
(SSPAC)

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:

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

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

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

Contact

 

CURRENT ENROLLMENT

Currently, 50 patients from 20 centers in The Netherlands, United Kingdom, United States, Italy, Norway, Finland, Slovenia, Spain and Germany 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
Lübeck University Hospital, Lübeck, Germany Prof. Tobias Keck Dr. Lars Tharun
King’s College Hospital, London, UK Dr. Krishna Menon Dr. Zen
Total inclusions  

50

 

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
Load More Posts

Events:

E-AHPBA/E-MIPS REGISTRY

1 June 2019 @ 08:00 - 1 June 2021 @ 17:00 CEST

Endorsed by:

Swedish Study Group
for Pancreatic Cancer
(SSPAC)