Clinical Research Directory

Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)

Sponsor: University Hospital, Montpellier

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

Official title: Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial

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