High-concentration Small-volume Versus Low-concentration Large-volume Iodine Solution for Esophageal Chromoendoscopy: a Multicenter, Randomized Equivalence Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 试验地点
- 5
- 主要终点
- Visual analogue scale scores at 30 minutes after chromoendoscopy
研究概览
简要总结
This clinical trial aims to test the participants' tolerance for different concentration iodine solutions during esophageal chromoendoscopy. The main question it aims to answer is:
Under the same iodine dosage, do the participants have the same tolerance for 1% and 5% iodine solutions? Participants will be asked to score based on pain and discomfort and describe symptoms and corresponding location at 5 minutes (only for unanesthetized participants) and 30 minutes after chromoendoscopy.
详细描述
Lugol's iodine chromoendoscopy is the commonly used method for detecting and diagnosing esophageal squamous cell carcinoma. However, iodine can induce mucosal irritation and has been commonly associated with adverse retrosternal symptoms, including retrosternal pain and/or heartburn. The existing research shows that spraying iodine solution neutralizers (Sodium thiosulfate solution, N-acetylcysteine, and vitamin C solution) after esophageal iodine chromoendoscopy can alleviate patient discomfort. However, a recent study has shown that excessive iodine concentration or excessive dosage of iodine can still increase patient discomfort even under spraying an iodine solution neutralizer. It is currently unclear whether the factors affecting patient tolerance are the iodine solution concentration or the total dosage of iodine used. Therefore, the multicenter randomized controlled trial will compare the patient's tolerance for the 1% and 5% iodine solutions under the same iodine dosage conditions. The trial will help determine the specific reasons influencing patient tolerance. Participants will be asked to score based on pain and discomfort and describe symptoms and corresponding location at 5 minutes (only for unanesthetized participants) and 30 minutes after chromoendoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing esophageal Lugol's iodine chromoendoscopy.
排除标准
- •Patients allergic to iodine or with hyperthyroidism;
- •Patients with 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 who could not cooperate with the observation and data collection including patients with mental disorders, severe neurosis, dysgnosia or communication disorder;
- •Patients with advanced-stage tumors;
- •Patients after upper gastrointestinal surgery;
- •Patients who do not agree to sign informed consent forms or follow the trial requirement.
研究组 & 干预措施
1% iodine solution arm
Esophageal chromoendoscopy will be performed with a 15 ml volume of 1% Lugol iodine solution.
干预措施: 1% Lugol's iodine solution (Drug)
5% iodine solution arm
Esophageal chromoendoscopy will be performed with a 3 ml volume of 5% iodine stock solution.
干预措施: 5% Lugol's iodine solution (Drug)
结局指标
主要结局
Visual analogue scale scores at 30 minutes after chromoendoscopy
时间窗: 30 minute after endoscopy
According to the visual analogue scale, participants will be asked to score based on pain or discomfort 30 minutes after chromoendoscopy.
次要结局
- The color objective evaluation after chromoendoscopy(2-3 minutes after spraying Lugol's iodine.)
- The color subjective evaluation after chromoendoscopy(During endoscopy.)
- The dosage of additional iodine spraying(During endoscopy)
- The incidence rate of esophageal spasms(During endoscopy)
- The incidence rate of adverse incidents(Up to 48 hours after the endoscopy)
- Associated factors for visual analogue scale scores(Up to 48 hours after the endoscopy)
- The incidence rate of the need for additional iodine solution spraying(During endoscopy.)
- Heart rate variability(5 minute or 30 minute after endoscopy)
- Visual analogue scale scores at 5 minutes after chromoendoscopy(5 minute after endoscopy)
- The incidence rate of upper abdominal discomfort or pain.(5 minute or 30 minute after endoscopy)
研究者
Zhiguo Liu
Associate professor
Xijing Hospital of Digestive Diseases