The Effects of Premedication With Pronase and Postural Exercise on Mucosal Cleanliness During Painless Esophagogastroduodenoscopy: A Prospective, Multicenter, Randomized Controlled Study Based on Artificial Intelligence Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Mucosal Cleanliness Scores
研究概览
简要总结
Gastric cancer and esophageal cancer are common malignant tumors that threaten people's life and health. Esophagogastroduodenoscopy (EGD) is an important tool for screening upper gastrointestinal tumors, especially early tumors, and an effective method for detecting other upper gastrointestinal lesions, including ulcers and polyps. However, during EGD examination, mucus and foam can reduce the cleanliness of the mucosa and limit the operator's visual field, resulting in missed lesions and misdiagnosis. Previous studies have shown that preoperative medication with pronase and dimeticone is correlated with the improvement of upper gastrointestinal mucosal cleanliness. However, the number of samples in such studies is limited, and the artificial judgment is not objective enough to evaluate the cleanliness of upper digestive tract mucosa. And, whether a postural exercise is necessary for premedication with pronase or dimeticone remains unclear. Our team design this experiment to examine the efficacy of using premedication of dimeticone/pronase with a postural exercise on visualization of the mucosa before painless EGD. The investigators aim to provide new evidence to optimize the use of premedication with EGD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged ≥18 years and ≤70 years;
- •Voluntarily participate in the trial and sign the informed consent.
排除标准
- •active gastrointestinal bleeding;
- •esophageal stricture, complete pyloric obstruction and gastroparesis caused by various reasons;
- •diagnosed malignant tumors of the upper digestive tract;
- •a history of upper gastrointestinal surgery;
- •severe heart, liver and kidney diseases, and the doctor judges that it is not suitable for painless gastroscopy;
- •serious mental illness;
- •pregnancy or breastfeeding;
- •an allergy to pronase or dimeticone;
- •current participation in other clinical trials and in the follow-up or drug washout period;
- •patients considered by the investigator to be unsuitable for this study
研究组 & 干预措施
A1:Dimeticone+Pronase+Postural Exercise group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder and 20,000 IU pronase granules combined with 1 g NaHCO3. Then the patients are asked to take a 3-minute postural exercise.
干预措施: Dimethicone+Pronase (Drug)
A1:Dimeticone+Pronase+Postural Exercise group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder and 20,000 IU pronase granules combined with 1 g NaHCO3. Then the patients are asked to take a 3-minute postural exercise.
干预措施: with Postural Exercise (Behavioral)
A2:Dimeticone+Pronase group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder and 20,000 IU pronase granules combined with 1 g NaHCO3. Then the patients sit quietly awaiting examination.
干预措施: Dimethicone+Pronase (Drug)
A2:Dimeticone+Pronase group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder and 20,000 IU pronase granules combined with 1 g NaHCO3. Then the patients sit quietly awaiting examination.
干预措施: without Postural Exercise. (Behavioral)
B1:Dimeticone+Postural Exercise group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients are asked to take a 3-minute postural exercise.
干预措施: Dimethicone (Drug)
B1:Dimeticone+Postural Exercise group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients are asked to take a 3-minute postural exercise.
干预措施: with Postural Exercise (Behavioral)
B2:Dimeticone group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients sit quietly awaiting examination.
干预措施: Dimethicone (Drug)
B2:Dimeticone group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients sit quietly awaiting examination.
干预措施: without Postural Exercise. (Behavioral)
结局指标
主要结局
Mucosal Cleanliness Scores
时间窗: Through study completion, an average of 1 year
The upper digestive tract is divided into 9 anatomical parts, including esophagus, squamocolumnar junction, middle-upper gastric body, lower gastric body, gastric antrum, duodenal bulb, duodenal descending, gastric angulus and gastric fundus. The mucosal cleanliness score of each segment is classified as 0-3. Score0: any solid food, blood or blood clots, or other content that could not be suctioned or washed, or an obstruction that prevented adequate visualization of the majority of an anatomical area. Score 1: mucus, bubbles, liquid content, and blood that required suctioning AND/OR washing. Score 2: nonadherent liquid content or blood that required ONLY suctioning but NOT washing. Score 3: entire mucosa well seen without the need for suctioning or washing. The sum of the mucosal cleanliness scores for the above mentioned 9 locations ranges from 0 to 27.
次要结局
- Procedure Time(Through study completion, an average of 1 year)
- The Detection Rate of Diminutive Lesions(Through study completion, an average of 1 year)
- Safety of antifoam/mucus agents(Through study completion, an average of 1 year)
研究者
Luowei Wang, MD
Clinical Professor
Changhai Hospital