Perioperative Platelet Inhibition With Acetylsalicylic Acid in Patients With Resectable Tumors of the Pancreatic Head

Launched by GERMAN CANCER RESEARCH CENTER · Nov 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether taking aspirin before and after surgery can help patients with resectable pancreatic cancer avoid the spread of cancer (metastasis) after their tumors are removed. Participants will begin taking a daily aspirin tablet 1 to 4 weeks before their surgery and continue for 6 months after the surgery. The goal is to see if this treatment makes a difference in how well patients do after their operation.

To be eligible for the trial, participants should be between 18 and 80 years old and have a specific type of pancreatic cancer that can be surgically removed. They must also be able to give written consent to join the trial and have a certain level of health. Participants will need to attend regular follow-up visits to monitor their progress. This trial is not yet recruiting patients, but it offers an opportunity for those with the right conditions to potentially benefit from this approach to treatment.

Gender

ALL

Eligibility criteria

• 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)