2023-503349-71-00招募中2 期
TransNiDeG - The Effect of Transcutaneous Nicotine Administration on the Development of Delayed Gastric Emptying following Pancreatoduodenectomy - a randomized, placebo-controlled, double-blind, multicenter trial
Rheinische Friedrich Wilhelms Universitaet Bonn7 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年8月7日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 7
- 主要终点
- Grade of delayed gastric empyting (none, grades A-C representing increasing severity) according to the definition of the International study Group of Pancreatic Surgery
研究概览
简要总结
To assess the effect of transcutaneous administration of nicotine as compared to placebo on the development and severity of delayed gastric emptying (DGE) following pancreatoduodenectomy
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •subject aged ≥ 18 years
- •given written informed consent to participate in the trial
- •planned for pancreatoduodenectomy
- •smokers must be willing to stop smoking for the duration of the IMP application (i.e. from Day 1 to Day 7)
排除标准
- •Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial
- •Immediately after heart attack
- •Severe cardiac arrhythmia
- •Stroke that occurred shortly before
- •Simultaneous participation in a clinical trial taking an investigational medicinal product, up to 30 days prior to last IMP intake in that clinical trial
- •Current or planned pregnancy or nursing women
- •Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contracep-tives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases
- •Distant organ metastases (which can be diagnosed after screening, e.g. during surgery; then no resection is performed according to guidelines)
- •former gastrectomy
- •liver fibrosis/cirrhosis
- •Known history of hypersensitivity to nicotine or a compound of the investigational drug
- •Systemic skin diseases
结局指标
主要结局
Grade of delayed gastric empyting (none, grades A-C representing increasing severity) according to the definition of the International study Group of Pancreatic Surgery
Grade of delayed gastric empyting (none, grades A-C representing increasing severity) according to the definition of the International study Group of Pancreatic Surgery
次要结局
- postoperative pancreatic fistula
- postpancreatectomy hemorrhage
- intraabdominal fluid collections
- surgical site infections
- re-intervention rate
- re-operation rate
- Clavien-Dindo classification
- MTL30 score
- quality-of-life questionnaires (QLQ-C30 and PAN26)
- mortality
- cardiovascular events ((non-fatal) myocardial infarction, (non-fatal) stroke, revascularization during admission)
- requirement of naso-gastric tube (NGT) in the first 21 days after surgery
- inability to tolerate solid oral food in the first 21 days after surgery
- vomiting/gastric distension in the first 21 days after surgery
- use of prokinetics in the first 21 days after surgery
- Adverse Events and Serious Adverse Events
研究者
PD Dr. Tim Glowka
Scientific
Rheinische Friedrich Wilhelms Universitaet Bonn
研究点 (7)
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