DRKS00014054进行中（未招募）2 期
Pancreatic resection with perioperative off-Label study of Propranolol and Etodolac - A Phase II randomized Trial - PROSPER
niversitätsklinikum Heidelberg0 个研究点目标入组 26 人开始时间: 2018年8月29日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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