EUCTR2018-004239-63-NL进行中（未招募）1 期
Botulinum toxin (BOTOX®) to prevent post-operative pancreatic fistula in patients who undergo distal pancreatectomy. PROFIT study. - PROFIT
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age = 18 years.
- •Lesion(s) of the body and/or tail of the pancreas for which open, laparoscopic or robot-assisted distal pancreatectomy will be performed.
- •Signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Hypersensitivity to BOTOX (or the components in the BOTOX formulation).
- •American Society of Anesthesiologists score >III.
- •Unable to undergo duodenoscopy (due to any anatomic condition).
- •Pregnancy or lactation.
- •Serious concomitant systemic disorders that would compromise the safety of the patient or his/her ability to complete the study, at the discretion of the investigator.
研究者
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