Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.

Korábbi kezelés

• History of stroke or any previous cardiovascular event.

Más betegség

• Asthma or chronic obstructive lung disease
• Liver insufficiency defined as chronically high liver enzymes or known chronic liver disease (e.g., hepatitis, steatosis, cirrhosis).
• Severe peripheral circulatory disorders
• Known hypersensitivity to propranolol or to one or more of the excipients.
• History of Prinzmetals angina.
• History of sick sinus syndrome or atrioventricular block.
• History of neoadjuvant oncological treatment for suspected primary pancreatic cancer.
• Predictable poor compliance, due to pre-existing psychiatric disease, dementia or not able to read or speak sufficient Danish, resulting in not being able to provide a well-informed written consent.

Laborértékek

• Heart insufficiency with affected (< 50 %) left ventricle ejection fraction (LVEF), treated or untreated.
• Kidney insufficiency, defined as eGFR < 20 ml/min.
• Recent or present (within 3 months) use of any of the following medications: anxiolytics, calcium channel blockers, beta-adrenergic receptor agonist.

Egyéb

• Patients with:
• Chronic hypotension, systolic blood pressure < 100 mg Hg for women and < 110 mg Hg for men.
• Bradycardia, pulse < 50 beats per minute.
• Cor pulmonale
• Cardiogenic shock
• Known or newly diagnosed current metabolic acidosis (e.g., in recent analysis of arterial puncture).
• Currently untreated pheochromocytoma.
• Recent or present (within 3 months) use of propranolol or any other beta-blocker.
• Medical history that classifies the patient as frail or unsuitable for inclusion by the examining physician.
• Histopathological examination revealing benign lesion.

• Patients with suspected surgically resectable pancreatic cancer
• Indication for surgical treatment with curative intend.
• Provide written informed consent.
• Patients minimum 18 years old.
  • Women of childbearing potential (WOCBP) are defined as women ranging from the period of menarche till the post-menopausal period, unless permanently sterile (e.g., hysterectomy, bilateral salpingectomy and bilateral oophorectomy). Post-menopause is defined as no menses for 12 months without an alternative medical cause.
  • WOCBP should use a secure and highly effective birth control (as stated in the "Recommendations related to contraception and pregnancy testing in clinical trials", version 1.1., section 4.1, from the Clinical Trials Facilitation and Coordination Group) during the entire period of the trial. In cases of uncertainty regarding pregnancy, additional pregnancy testing either as highly sensitive serum or urine pregnancy test can be used.