Trial coordinators
Quirine Tielens, MD
Charlotte Baggerman van Houweninge, MD
Principal Investigators
Prof. Mohammad Abu Hilal, MD PhD FRCS FACSProf. Marc G. Besselink, MD MSc PhD
Why this trial matters
Minimally invasive left pancreatectomy (MILP) is the recommended approach for benign and low-grade malignant lesions of the pancreas, with consistently favorable outcomes compared with open left pancreatectomy (OLP).
Within MILP, robot-assisted procedures (R-MILP) are increasingly adopted due to potential technical advantages, including three-dimensional visualisation and enhanced instrument dexterity, which may translate into reduced postoperative morbidity. However, multiple studies have demonstrated higher procedural costs for R-MILP compared with laparoscopic MILP (L-MILP).
At the same time, retrospective comparative studies have shown similar morbidity and mortality between laparoscopic and robot-assisted approaches, raising the question whether the additional costs of R-MILP are justified in routine practice.
An additional clinically relevant aspect is spleen preservation. This is particularly important in benign and low-grade malignant disease, where preservation of the spleen is desirable to avoid the long-term immunological and hematological consequences associated with splenectomy. It is hypothesized that a robot-assisted approach may facilitate higher spleen preservation rates compared with laparoscopy, particularly in anatomically challenging cases, due to improved dexterity and visualisation. In addition, the trial will assess whether the intended operative strategy, including planned spleen preservation and the chosen technique (Kimura or Warshaw), can be successfully achieved using either a laparoscopic or robot-assisted approach.
To date, no randomized controlled trial has directly compared laparoscopic and robot-assisted left pancreatectomy. The DIPLOMA-3 trial was designed to fill this evidence gap.
About the trial
DIPLOMA-3 is an international, multicenter, patient-blinded randomized controlled trial conducted in high-volume pancreatic centers. Participating centers must have performed at least 85 minimally invasive pancreatic resections (MIPR), and participating surgeons must have a minimum personal experience of 30 MIPR, including both left pancreatectomy and pancreatoduodenectomy, performed either laparoscopically or robot-assisted.
To ensure methodological rigor and that both techniques are considered appropriate within each center, participating centers must be able to perform both L-MILP and R-MILP, allowing within-center randomization.
Study population
Patients with an indication for elective MILP for benign or low-grade malignant lesions located in the pancreatic body or tail, and who are considered suitable for either a laparoscopic or robot-assisted approach, are eligible for inclusion.
Inclusion criteria:
Age ≥18 years
Indication for elective left pancreatectomy, either spleen-preserving or non-spleen-preserving, for proven or suspected left benign or premalignant disease
Both robot-assisted and laparoscopic left pancreatectomy are considered technically feasible by the local treatment team
Fit to undergo left pancreatectomy
Written informed consent
Exclusion criteria:
Suspected pancreatic ductal adenocarcinoma
Tumor or cyst >8 cm
Requirement for resection or ablation of organs other than the pancreas and spleen
Tumor involvement or abutment of major vessels (celiac trunk, superior mesenteric artery, or vena cava)
Pregnancy
Body mass index >40 kg/m²
Participation in another interventional study that may interfere with study outcomes
Randomization
Patients are randomized in a 1:1 ratio to L-MILP or R-MILP using a secure online randomization system, with stratification based on planned spleen preservation and the intended spleen-preserving technique.
Outcomes
Primary outcome
The primary endpoint is the COMPOS-panc left score, a composite, severity-weighted measure integrating perioperative and postoperative outcomes up to 90 days after surgery. The study is designed as a non-inferiority trial for this endpoint. It includes:
Unplanned blood transfusion
Conversion to open surgery
Postoperative pancreatic fistula (POPF)
Postpancreatectomy haemorrhage (PPH)
Other complications requiring intervention
Multi-organ failure
Mortality
Length of hospital stay
Readmission requiring intervention
Secondary outcomes
The key secondary endpoints are total hospital-related costs and spleen preservation.
For total hospital-related costs, L-MILP is hypothesized to be superior, reflecting lower procedural and perioperative expenditure compared with R-MILP. Cost analyses will include direct operative costs, in-hospital costs, and all follow-up-related healthcare utilization within 90 days, including readmissions, outpatient visits, emergency department visits, and reinterventions.
For spleen preservation, R-MILP is hypothesized to be superior, based on the expectation that improved dexterity and visualisation may facilitate higher rates of spleen-preserving procedures.
Additional secondary endpoints include:
Intraoperative outcomes (type of resection, blood loss, operative time, conversion rate, pancreatic transection technique, spleen-preserving strategy including Kimura and Warshaw procedures, vascular or extended resections)
Postoperative pain
Postoperative morbidity (Clavien–Dindo classification, surgical site infection, non-surgical complications, and pancreatic-specific complications according to ISGPS definitions)
Healthcare resource utilization (including ICU stay)
Surgeon workload, including mental and physical strain
Patient-reported quality of life
How surgeons can get involved
Centers meeting the above quality criteria are still welcome to join the trial. For participation inquiries, please contact:
Quirine E.M. Tielens, MD, PhD candidate HPB Surgery Amsterdam UMC
Email: q.e.tielens@amsterdamumc.nl
Website: DIPLOMA-3
ClinicalTrials.gov ID: NCT06939023
