Status:
RECRUITING
Examining Safety, Efficacy and Feasibility of Preoperative Propranolol in Patients With PDAC.
Lead Sponsor:
Zealand University Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Pancreatic Cancer
Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The IMPULS trial is a randomized, triple-blinded, placebo controlled, single center, pilot trial examining the efficacy and safety of preoperative propranolol in patients scheduled for pancreatic canc...
Detailed Description
The study will be conducted as a pilot study to test efficacy, safety and feasibility of propranolol on preoperative anxiety in patients undergoing abdominal surgery for suspected pancreatic ductal ad...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients with:
- Chronic hypotension, systolic blood pressure \< 100 mg Hg for women and \< 110 mg Hg for men.
- Bradycardia, pulse \< 50 beats per minute.
- Asthma or chronic obstructive lung disease
- Heart insufficiency with affected (\< 50 %) left ventricle ejection fraction (LVEF), treated or untreated.
- Kidney insufficiency, defined as eGFR \< 20 ml/min.
- Liver insufficiency defined as chronically high liver enzymes or known chronic liver disease (e.g., hepatitis, steatosis, cirrhosis).
- Cor pulmonale
- Cardiogenic shock
- Severe peripheral circulatory disorders
- Known or newly diagnosed current metabolic acidosis (e.g., in recent analysis of arterial puncture).
- Known hypersensitivity to propranolol or to one or more of the excipients.
- Currently untreated pheochromocytoma.
- History of Prinzmetals angina.
- History of sick sinus syndrome or atrioventricular block.
- History of stroke or any previous cardiovascular event.
- History of neoadjuvant oncological treatment for suspected primary pancreatic cancer.
- Recent or present (within 3 months) use of propranolol or any other beta-blocker.
- Recent or present (within 3 months) use of any of the following medications: anxiolytics, calcium channel blockers, beta-adrenergic receptor agonist.
- Medical history that classifies the patient as frail or unsuitable for inclusion by the examining physician.
- Histopathological examination revealing benign lesion.
- 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.
Key Trial Info
Start Date :
March 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2035
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06145074
Start Date
March 20 2024
End Date
December 31 2035
Last Update
March 28 2024
Active Locations (2)
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1
Department of Surgical Gastroenterology
Copenhagen, Denmark, 2200
2
Ismail Gögenur
Køge, Denmark, 4600