Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT05637567
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05637567
Study Brief:
Protocol Section:
NCT05637567