Perioperative Platelet Inhibition With Acetylsalicylic Acid Targeting Intraoperative Tumor Cell Seeding in Patients With Resectable Tumors of the Pancreatic Head - a Randomized, Controlled Multicenter Study

DKFZ-2022-006

This randomized, controlled clinical trial compares the perioperative treatment with acetylsalicylic acid (aspirin) in patients with cancer of the pancreatic head. The main question it aims to answer is: Do patients treated perioperatively with aspirin develop less metastasis after curative resection of pancreatic head tumors? Participants will be asked to : * take a daily aspirin tablet starting 1-4 weeks before surgery until 6 months after surgery * participate in regular follow-up visits.

2024-04-01

2028-09-01

2029-03-01

Not yet recruiting

Early phase I

170

Inclusion Criteria: 1. Indication: Patients with (histologically confirmed or clinically suspected) surgically resectable, non-metastatic ductal adenocarcinoma of the pancreatic head 2. Patients planned for pylorus-preserving partial pancreaticoduodenectomy (PPPD / "ppWhipple" / Traverso-Longmire procedure) (conventional or minimally invasive) 3. Male and female patients aged 18 to 80 years 4. Written informed consent of the participating person 5. ECOG≤2 Exclusion Criteria: 1. Metastatic disease (distant or peritoneal metastases or lymph node involvement considered distant metastasis (i.e., interaortocaval nodes)) 2. Preoperative use of anticoagulants / thrombolytics (e.g. warfarin, heparin), platelet aggregation inhibitors (e.g. ASA, ticlopidine, clopidogrel), chronic NSAID or metamizole use 3. Neoadjuvant treatment for locally advanced disease 4. Presumed necessity of arterial resection (other than gastroduodenal artery) 5. Advanced liver (INR \>1.5 or hepatic encephalopathy) or renal failure (stage IV or higher) 6. Advanced heart disease (NYHA class ≥ 3) 7. Known hypersensitivity to ASA or to drugs with a similar chemical structure 8. History of asthma attacks triggered by salicylates or substances with similar effects 9. Haemorrhagic diathesis, blood coagulation disorders such as haemophilia or thrombocytopenia 10. Thrombocytosis \> 450,000 / μL 11. Methotrexate at a dosage of 15 mg or more per week 12. Participation in competing trials affecting the effects of the investigational medicinal product (IMP) or outcome measures 13. Addictive or other medical conditions that do not allow the subject to appreciate the nature and scope of the clinical trial and its potential consequences 14. Pregnant or breast-feeding women 15. Women of childbearing potential, except women who meet the following criteria: * Post-menopausal (12 months natural amenorrhoea or six months amenorrhoea with serum follicle-stimulating hormone (FSH) \> 40 U/ml) * Postoperative (six weeks after bilateral ovariectomy with or without hysterectomy) * Regular and correct use of a contraceptive method with a failure rate \< 1% per year (e.g. implants, depot injections, oral contraceptives, intrauterine devices) * Sexual abstinence * Vasectomy of partner 16. Indications that the patient is unlikely to comply with the protocol (e.g. unwillingness to cooperate)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 170, 'type': 'ESTIMATED'}}

2023-11-13