The Efficacy of N-acetylcysteine on Alleviating Symptom Caused by Lugol Chromoendoscopy: a Prospective, Non-inferiority, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mean Visual analogue scale change
研究概览
简要总结
Lugol chromoendoscopy is essential in detecting and characterizing squamous cell carcinoma of esophagus. Esophageal irritating symptom has been reported as an common adverse event, which could be alleviated by sodium thiosulfate solutions. However, sodium thiosulfate was not widely available. N-acetylcysteine has been previously used as a mucolytic reagent, we propose that it may also be used to alleviate irritating symptoms caused by Lugo's chromoendoscopy. A prospective, non-inferior, randomized double-blind clinical trial was designed to study the efficacy of N-acetylcysteine solutions in relieving esophageal discomfort .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients at risk of esophageal squamous cell cancer including those over 50 years old, or over 45 years old with family history of esophageal squamous cell cancer;
- •Patients with suspected esophageal lesions by screening endoscopy;
- •Patients requiring surveillance after endoscopic resection or radiotherapy for esophageal squamous cell cancer one year later。
排除标准
- •Patients allergic to iodine or with hyperthyroidism;
- •Patients with advanced esophageal cancer, esophageal varices, esophageal ulcer or other conditions inadvisable for Lugol chromoendoscopy;
- •Patients with severe gastroesophageal reflux disease or reflux symptoms which may interfered with the outcome measures of current study;
- •Patients with postoperative esophageal stenosis affecting endoscopic observation;
- •Patients with serious comorbidities that cannot tolerate un-sedated gastroscopy;
- •Patients who could not cooperate with the observation including patients with mental disorders, severe neurosis or dysgnosia;
- •Patients undergoing sedation or general anesthesia during endoscopy.
- •Patients who do not agree to sign informed consent forms or follow the trial requirement.
研究组 & 干预措施
sodium thiosulfate solution arm
20ml of 5% sodium thiosulfate solution were prepared with 1g sodium thiosulfate crystal dissolved in normal saline in a 20 ml syringe
干预措施: sodium thiosulfate solution (Drug)
N-acetylcysteine solution arm
20ml of 3% N-acetylcysteine solution were prepared with one piece of N-acetylcysteine effervescent tablet （ net weight 0.6g ）dissolved in normal saline in a 20 ml syringe
干预措施: N-acetylcysteine solution (Drug)
结局指标
主要结局
Mean Visual analogue scale change
时间窗: 30 minute after endoscopy
Visual analogue scale change for esophageal irritation after Lugol chromoendoscopy
次要结局
- Heart rate variability(5 minute or 30 minute after endoscopy)
- exam time(during endoscopy)
- Neutralization rate(During endoscopy)
- Severe discomfort rate(5 minute or 30 minute after endoscopy)
- Rate of patients with symptom(5 minute or 30 minute or 24 hour after endoscopy)
研究者
Zhiguo Liu
associate professor
Xijing Hospital of Digestive Diseases