Health Trials

Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)

ConditionsPancreatectomyDistal Pancreatectomy (DP)Pancreatic NeoplasmsPancreatic AdenomaPancreatic CystPancreatic CystadenomaSurgeryMinimally Invasive Surgical TechniqueMinimally Invasive Distal PancreatectomyMinimally Invasive Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.

Eligibility criteria

Qualifiers

Age at least 18 years;

Indication for elective left-sided pancreatectomy, either spleen-preserving or non-preserving (because of proven or suspected left-sided benign or premalignant disease);

Both robot-assisted and laparoscopic left-sided pancreatectomy are technically feasible for resection, according to the local treatment team;

Fit to undergo left-sided pancreatectomy according to the surgeon and anaesthesiologist;

Disqualifiers

Suspected pancreatic ductal adenocarcinoma;

Tumor or cyst larger than 8 cm;

Required resection or ablation of organs other than pancreas and spleen;

Tumor involvement or abutment of major vessels (celiac trunk, mesenteric artery or vena cava);

Trial design

Treatments tested in this trial

  • Laparoscopic minimally invasive left-sided pancreatecomy
  • Robot-assisted minimally invasive left-sided pancreatecomy

Treatment groups

256 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Lead sponsor

Leiden University Medical Center

Collaborator

Catharina Ziekenhuis Eindhoven

Collaborator

Erasmus Medical Center

Collaborator

Medisch Spectrum Twente

Collaborator

Maastricht University Medical Center

Collaborator

University Medical Center Groningen

Collaborator

Onze Lieve Vrouwe Gasthuis

Collaborator

Source ClinicalTrials.gov