Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA) (NCT04483726) | Clinical Trial Compass
CompletedNot Applicable
Distal Pancreatectomy, Minimally Invasive or Open, for Malignancy (DIPLOMA)
France9 participantsStarted 2020-07-09
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.