DRKS00010080招募中3 期
Multicenter, randomized, controlled, open-label, phase-III clinical trial of PREoperative endoscopic injection of BOTulinum toxin in the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy (PREBOT trial) - PREBOT
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial Director0 个研究点目标入组 254 人开始时间: 2016年2月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 254
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients scheduled for elective DP, =18 years of age, Ability of subject to understand character and individual consequences of the clinical trial, Written informed consent, For women with childbearing potential, presence of negative urine or blood pregnancy test, and adequate contraception for the first 5 days after trial intervention
排除标准
- •Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months; congestive heart failure NYHA III/IV, unstable angina pectoris); Renal insufficiency, i.e. creatinine clearance <30 mL/min; Liver cirrhosis of any Child-Pugh grade; American Society of Anaesthesiologists (ASA) score >III; Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation; Neuromuscular disorder, e.g. peripheral motor neuropathic disease, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome), or any other neurological disorder with associated increased risk for the patient undergoing botulinum toxin injection; Any condition in which duodenoscopy and/or the trial intervention is not possible, e.g. for anatomical reasons, or obsolete in the actual situation, e.g. in patients with acute pancreatitis; History of botulinum toxin application and either positive test or missing test for neutralising antibodies to botulinum Toxin; Understanding or language problems; Inability to comply with study and/or follow-up procedures; Pregnancy or lactation; Concurrent participation in another interventional clinical trial, or participation within the previous 30 days before study enrollment (or longer exclusion period, if required by national or local regulations); Legally incapacitated patients; Patients held in an institution by legal or official order; Any condition or situation which could result in an undue risk for the patient and/or influence outcome measures in the opinion of the investigator
研究者
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