2024-517267-23-00招募中2 期
Botulinum toxin (BOTOX®) to prevent post-operative pancreatic fistula in patients who undergo distal pancreatectomy
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月25日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint of this pilot project is to determine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi. We deem this treatment feasible in case we can complete the proposed treatment in 14 out of 15 patients.
研究概览
简要总结
To examine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria: Age ≥ 18 years. Lesion(s) of the body and/or tail of the pancreas for which open, laparoscopic or robotassisted distal pancreatectomy will be performed. Signed informed consent.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study: 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.
结局指标
主要结局
The primary endpoint of this pilot project is to determine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi. We deem this treatment feasible in case we can complete the proposed treatment in 14 out of 15 patients.
The primary endpoint of this pilot project is to determine the feasibility and safety of preoperative endoscopic BOTOX® injection in the sphincter of Oddi. We deem this treatment feasible in case we can complete the proposed treatment in 14 out of 15 patients.
次要结局
- As a secondary endpoint we will investigate the effect of preoperative endoscopic BOTOX® injection in the sphincter of Oddi on the occurrence of postoperative pancreatic fistulas.
研究者
C.J. Pek
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (1)
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