DRKS00024061招募中2 期
Randomized controlled trial of PREoperative injection of BOTulinum toxin into the sphincter of Oddi to reduce bile leckage after hepatic resection - PREBOT-II Trial - PRBOT-II
Ruprecht-Karls-University HeidelbergMedical Faculty represented by Universitätsklinikum Heidelberg and its acting Commercial Director Katrin Erk0 个研究点目标入组 70 人开始时间: 2021年10月27日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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, primary liver resection with no planned biliary reconstruction
- •- Male or female patients =18 years of age
- •- Ability of patient to understand character and individual consequences of the clinical trial
- •- Written informed consent (available before enrollment)
- •- For women with childbearing potential, presence of negative urine or blood pregnancy test, and adequate contraception until 14 days after trial intervention
排除标准
- •- Patients who already underwent papillotomy for any reason or have an inlaying bile stent
- •-Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
- •- Serious renal insufficiency, i.e. creatinine clearance <30 mL/min
- •- Liver cirrhosis
- •- American Society of Anesthesiologists (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 neutralizing 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
- •- 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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