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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Apr 15, 2025

Keywords

ClinConnect Summary

The DIPLOMA-3 trial is a research study comparing two types of surgery for patients needing a left-sided pancreatectomy, which is the removal of part of the pancreas. This surgery is being studied for patients with non-cancerous or potentially cancerous conditions affecting the body or tail of the pancreas. The two methods being compared are laparoscopic surgery, which uses small incisions and special instruments, and robot-assisted surgery, which uses robotic technology to assist the surgeon. The goal is to see which method is safer and more effective for patients.

To be eligible for this trial, participants must be at least 18 years old and have a specific need for this type of surgery, as determined by their doctors. They should also be healthy enough to undergo the procedure, and both surgical options should be suitable for their situation. Patients will be randomly assigned to one of the two surgical methods, but they won’t know which one they are receiving to ensure a fair comparison. The trial is not yet recruiting participants, so those interested will need to wait for it to begin.

Gender

ALL

Eligibility criteria

• 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