Clinical trial · Interventional
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA): a Pan-European, Randomized Controlled, Multicenter, Patient Blinded, Non-inferiority Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective: To compare MIDP with ODP regarding radical resection rate for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail. Study design: A pan-European, randomized controlled, multicenter, patient-blinded non-inferiority trial. This protocol was designed according to the SPIRIT guidelines1. Pathologists judging the primary endpoint will be blinded for the surgical approach (MIDP vs ODP). A blinded adjudication committee will assess all endpoints. Study population: Two groups of 129 patients (258 in total) with an indication for elective distal pancreatectomy with splenectomy because of proven or highly suspected PDAC. Intervention: Minimally invasive distal pancreatectomy (either laparoscopic or robot-assisted) Control: Open distal pancreatectomy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| minimally invasive distal pancreatectomy | Procedure | — | UNRESOLVED |
| open distal pancreatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MIDP
- description
- minimally invasive distal pancreatectomy
- interventionNames
- Procedure: minimally invasive distal pancreatectomy
- type
- SHAM_COMPARATOR
- label
- ODP
- description
- open distal pancreatectomy
- interventionNames
- Procedure: open distal pancreatectomy
Primary outcomes (1)
- measure
- microscopically radical resection rate
- timeFrame
- 1 day
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years; * Elective indication for distal pancreatectomy for proven or suspected PDAC; * Upfront (without induction / down-sizing radio- and/or chemotherapy) resectable PDAC in the pancreatic body or tail; * The tumor can be radically resected via both minimally invasive or open surgery according to the local treating team; * The patient is fit to undergo both open and minimally invasive distal pancreatectomy Exclusion Criteria: * score of American society of anaesthesiologists (ASA) \>3; * A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria); * Second malignancy necessitating resection during the same procedure; * Distant metastases (M1) including involved distant lymph nodes; * Tumor involvement or abutment of major vessels (celiac trunk\*, mesenteric artery or portomesenteric vein); * Pregnancy; * Participation in another study with interference of study outcomes. * Cystic lesion having undergone malignant transformation * the celiac trunk should be 5mm clear from tumor
References
Publications (0)
Data not yet available