Pancreatic resection with perioperative off-Label study of Propranolol and Etodolac - A Phase II randomized Trial
- Conditions
- C25.0Head of pancreas
- Registration Number
- DRKS00014054
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 26
•Resectable malignancy of the pancreatic head, eligible for elective pancreatoduodenectomy in curative intent
•WHO / ECOG performance status 0-2
•Age = 18 years
•ASA score I-III
•Patient must be able to understand the consequences of trial participation and to provide written informed consent
•Written informed consent from the trial subject has been obtained
•Female subject must be postmenopausal (for at least 6 months), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription of oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and have a negative serum ß-hCG pregnancy test at screening
•Any contraindication for pancreatoduodenectomy
•Metastatic disease (Stage IV)
•Patients scheduled for palliative resection (no curative treatment intention)
•Patients scheduled for extended resections (arterial resections, planned multivisceral resections)
•Preoperative CA 19-9 > 400 U/ml
•Acute or ongoing episode of cholangitis (fever and pain in the right upper quadrant of the abdomen together with increased infectious parameters and elevated AP & GGT values)
•Acute or ongoing episode of pancreatitis (clinical symptoms of pancreatitis, increased lipase and/or CRP values, radiological or intraoperative signs of acute pancreatitis)
•Chronic neuropathy > grade 2
•Renal failure, measured by GFR <50ml/min/1,73 m² (calculated according to CKD-EPI)
•Known liver cirrhosis of any grade
•Atrioventricular block
•Previous neoadjuvant chemotherapy
•Pregnant or breastfeeding women
•Mental or organic disorders which could interfere with giving informed consent or receiving treatments
•Any contraindication to propranolol and/or etodolac:
-Known allergy or hypersensitivity to propranolol and/or etodolac or any other ingredient of the used brand
-History or evidence of significant cardiac disease: congestive or severe heart failure; New York Heart Association class = 2; active coronary artery disease; unstable angina, cardiac arrhythmias requiring anti-arrhythmic therapy, uncontrolled hypertension, patients with recent (less than 6 months) myocardial infarction or coronary revascularization; cardiogenic shock; sick sinus Syndrome; sinuatrial block; acidosis
-Hypotension at the time of screening (i.e., systolic blood pressure less than 100 mmHg. Diastolic blood pressure less than 60 mmHg)
-Symptomatic bradycardia or resting heart rate less than 50 bpm at time of Screening
-Bronchial hyperresponsiveness, including active chronic asthma
-Active peptic ulcer disease or gastrointestinal bleeding
-Decompensated diabetes mellitus (repeated measurements of glucose >300 mg/dl despite usual medical treatment, (keto-) acidosis, exsiccosis due to decompensated diabetes)
-Chronic inflammatory bowel disease (M. Crohn or Ulcerative colitis)
-Severe peripheral vascular disease
-Concurrent use of MAO inhibitor (excluding MAO-B inhibitor)
-Intravenous application of calcium channel blockers (Nondihydropyridine) and other antyarrhythmic agents
-Severe thrombocytopenia
-Sensitivity to Aspirin or other NSAIDs in Terms of athma, urticaria or acute rhinitis
-Chronic use of any beta-adrenergic blocker within the last 3 months.
-Chronic use of any COX inhibitor within the last 3 months.
-Participation in another interventional trial
-Pharmaceutical preparations with which major interactions can be expected by propranolol/etodolac in patients’ long-term therapy
-Diseases or findings that may have a significant effect on the target variables and which may therefore mask or inhibit the therapeutic effect under investigation
-Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
-Persons held in an institution by legal or official order; legally incapacitated patients
-Persons with understanding/language problems or inability to comply with study and/or follow-up procedures
-Any condition which could result in an undue risk for the patient and/or influence out-come measures in the opinion of the investigator
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method