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

With few symptoms, rapid progression and early metastasis pancreatic cancer (pancreatic ductal adenocarcinoma, PDAC) is the third leading cause of cancer death worldwide. In early stages of PDAC, surgical resection followed by adjuvant chemotherapy is the mainstay of treatment. Unfortunately, the majority of patients develop tumor recurrence (most frequently in the liver) despite complete resection and adjuvant treatment. This early postoperative recurrence is a result of preoperatively present, undetected micrometastases, and, most importantly, iatrogenic dissemination of circulating tumor...

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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)

Trial Officials