NCT04483726Completed
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 · Last updated 22 Jun 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 23 Jun 2020
- Start date
- 9 Jul 2020
- Primary completion date
- 29 Apr 2021
- Lead sponsor
- University Hospital, Montpellier
- Diseases
- Pancreatic cancer
- NCT number
- NCT04483726
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From 9 Jul 2020 to the primary completion date, 29 Apr 2021
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria);
- Second malignancy necessitating resection during the same procedure;
- Cystic lesion having undergone malignant transformation
- the celiac trunk should be 5mm clear from tumor
Other
- score of American society of anaesthesiologists (ASA) \>3;
- 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.
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Beaujon - APHP Coordinator of this site? Confirm its status | Clichy | France | Unknown status |
| CHU Saint Eloi - Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Centre Hospitalier Orléans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
| Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hôpital Paul-Brousse Coordinator of this site? Confirm its status | Villejuif | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.