RECRUITINGINTERVENTIONAL
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3): an International Multicenter Patient-blinded Randomized Controlled Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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 willing to sign a consent form
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
PROCEDURE
Laparoscopic minimally invasive left-sided pancreatecomy
Laparoscopic minimally invasive left-sided pancreatecomy
PROCEDURE
Robot-assisted minimally invasive left-sided pancreatecomy
Robot-assisted minimally invasive left-sided pancreatecomy
Locations (1)
Amsterdam UMC
Amsterdam, Netherlands