Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA): a pan-European, randomized controlled, multicenter, patient blinded, non-inferiority trial

niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 258 人开始时间: 2018年4月19日最近更新: 2024年6月10日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34503548/ (added 13/09/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37457332/ (added 17/07/2023)

•In order to be eligible to participate in this study, a patient must meet all of the following criteria:
•1. Age =18 years
•2. Elective indication for distal pancreatectomy for proven or suspected* PDAC
•3. Upfront (without induction/downsizing radio- or chemotherapy) resectable PDAC in the pancreatic body or tail**
•4. The tumor can be radically resected via both minimally invasive or open surgery according to the local treating team***
•5. The patient is fit to undergo both open and minimally invasive distal pancreatectomy
•*Pathology proof is not mandatory for two reasons, first it is not common practice in distal cancers to have this proof, so the decision for minimally invasive or open surgery will after the trial also depend on the ‘suspected’ diagnosis and second, there are even some concerns about the safety of endoscopic fine needle aspiration of distal pancreatic cancers with theoretical risk of peritoneal seeding
•**Malignant degenerated cysts are not allowed in the study. Neoadjuvant chemotherapy is only allowed in case of an upfront resectable tumor (neoadjuvant)
•**Multivisceral resections are allowed if, according to the local treating team, feasible with both, a minimally invasive and open approach

•Current exclusion criteria as of 19/05/2020:
•Patients that meet any of the following criteria will be excluded from participation in this study:
•1. American Society of Anesthesiologists classification >3
•2. A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria)
•3. Second malignancy necessitating resection during the same procedure
•4. Distant metastases (M1) including involved distant lymph nodes
•5. Tumor involvement or abutment of major vessels (celiac trunk*, mesenteric artery or portomesenteric vein);
•6. Pregnancy
•7. Participation in another study with interference of study outcomes
•*The celiac trunk should be 5mm clear from tumor
•Previous exclusion criteria:
•Patients that meet any of the following criteria will be excluded from participation in this study:
•1. ASA >3 (see appendix 17.3.2)
•2. A medical history of chronic pancreatitis (according to the M-ANNHEIM criteria, see Appendix for detailed definition)
•3. Second malignancy necessitating resection during the same procedure
•4. Radiotherapy because of pancreatic cancer prior to distal pancreatectomy
•5. Distant metastases (M1) including involved distant lymph nodes
•6. Tumor involvement or abutment of major vessels (celiac trunk*, mesenteric artery or portomesenteric vein);
•7. Pregnancy
•8. Participation in another study with interference of study outcomes
•*The celiac trunk should be 5mm clear from tumor

发起方

niversity Hospital Southampton NHS Foundation Trust