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

Summary

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.

Interventions

• Laparoscopic minimally invasive left-sided pancreatecomy · PROCEDURE

  Laparoscopic minimally invasive left-sided pancreatecomy

• Robot-assisted minimally invasive left-sided pancreatecomy · PROCEDURE

  Robot-assisted minimally invasive left-sided pancreatecomy

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* 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;
* Written informed consent

Exclusion Criteria:

* 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);
* Pregnancy;
* Body mass index \>40 kg/m2;
* Participation in another study with interference of study outcomes

Sites (1)

• Amsterdam UMC, Amsterdam, Netherlands · RECRUITING