Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
Pancreatic Cancer
Unknown Primary
18 Years and older, Male and Female
RECHMPL19_0340 (primary)
NCI-2022-02070
Summary
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, randomized controlled, multicenter, patient-blinded
non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1.
Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP
vs ODP). A blinded adjudication committee will assess all endpoints.
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
Objectives
Rationale: Several systematic reviews have suggested superior short term 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 regarding
the oncologic safety (i.e. radical resection, lymph node retrieval and survival) of MIDP
in pancreatic cancer. Most surgeons stated that a randomized 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, randomized controlled, multicenter, patient-blinded
non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1.
Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP
vs ODP). A blinded adjudication committee will assess all endpoints.
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 survival, lymph node retrieval,
intraoperative outcomes (such as blood loss, operative time and conversion),
postoperative outcomes (such as complications, time to functional recovery and hospital
stay) and quality of life
Eligibility
- = 18 years;
- Elective indication for distal pancreatectomy for proven or suspected PDAC;
- Upfront (without induction / down-sizing radio- and/or chemotherapy) resectable PDAC in the pancreatic body or tail;
- The tumor can be radically resected via both minimally invasive or open surgery according to the local treating team;
- The patient is fit to undergo both open and minimally invasive distal pancreatectomy
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