Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Detection rate of high grade dysplasia and carcinoma in iodine void lesion
研究概览
简要总结
Lugol's solution staining was regarded as a gold standard to detect early superficial lesion during esophageal cancer screening using endoscopy. However, the sensitivity and specificity were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was previously shown to improve the visibility of gastrointestinal tract. It's unknown if the pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A randomized double-blind clinical trial was designed to investigate whether or not pronase might improve detection rate of early esophageal lesion, especially high grade dysplasia and early cancer by improving the esophageal visibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 60 years to 75 years old
- •Patients less than 60 years old, but with one or multiple high risk factors for esophageal cancer including smoking and drinking addiction,family history of esophageal cancer, personal history of esophageal or head and neck malignancies, previous endoscopy documenting iodine void superficial lesion.
排除标准
- •Allergy to iodine or any other medicine which used in this trial.
- •Previous endoscopy revealing advanced esophageal cancer or other non-superficial lesions.
- •Conditions interfering visibility of endoscope including gastrointestinal obstruction and upper gastrointestinal bleeding.
- •Anatomic variation by surgery.
- •Pregnancy
- •Other conditions which investigator consider the patient at high risk for complications.
研究组 & 干预措施
Pronase
Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.
干预措施: Pronase (Drug)
control
No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.
干预措施: Control (Drug)
结局指标
主要结局
Detection rate of high grade dysplasia and carcinoma in iodine void lesion
时间窗: 1 week
Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）\*100%
次要结局
- Average Esophageal Visibility Score Before iodine staining(30 min after ingesting pretreatment solution)
- Average Esophageal Visibility Score After iodine staining(within 5 min after iodine staining)
- Detection Rate of lesions with pink sign(within 5 min after iodine staining)
- overall detection rate of iodine void lesion(within 5 min after iodine staining)
研究者
Zhiguo Liu
Associate Professor
Xijing Hospital of Digestive Diseases