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.
Indication: Patients with (histologically confirmed or clinically suspected) surgically resectable, non-metastatic ductal adenocarcinoma of the pancreatic head
Patients planned for pylorus-preserving partial pancreaticoduodenectomy (PPPD / "ppWhipple" / Traverso-Longmire procedure) (conventional or minimally invasive)
Male and female patients aged 18 to 80 years
Written informed consent of the participating person
Metastatic disease (distant or peritoneal metastases or lymph node involvement considered distant metastasis (i.e., interaortocaval nodes))
Preoperative use of anticoagulants / thrombolytics (e.g. warfarin, heparin), platelet aggregation inhibitors (e.g. ASA, ticlopidine, clopidogrel), chronic NSAID or metamizole use
Neoadjuvant treatment for locally advanced disease
Presumed necessity of arterial resection (other than gastroduodenal artery)
Parallel
Acetylsalicylic acid
Drug100 mg per os once daily
Placebo
DrugPlacebo pill per os once daily
Hematogenous metastases-free survival
The primary efficacy endpoint of the study is hematogenous metastases-free survival (HMFS), which is defined as the time from the day of surgery to the date of diagnosis of hematogenous distant metastases (e.g., hepatic or pulmonary metastases) or date of death from any cause, whichever comes first. Peritoneal metastases (peritoneal carcinomatosis) are not regarded hematogenous metastases. The HMFS status is evaluated at regular follow-up examinations for 36 months postoperatively and further recorded during clinical follow-up visits until the end of the trial.
Overall survival
Overall survival (OS) is defined as the time from the day of surgery until death from any cause.
Cancer-specific survival
Cancer-specific survival (CSS) is defined as the time from the day of surgery until death due to the treated cancer or a treatment-related complication.
Disease-free survival
Disease-free survival (DFS) is defined as the time from the day of surgery to the date of diagnosis of tumor recurrence (in any location) or to the date of death from any cause, whichever comes first.
Intraoperative blood loss
Intraoperative blood loss is documented in milliliters during surgery and subsequently analyzed. Intraoperative transfusions of blood or blood components will also be recorded and analyzed.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
