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
Trial ID: NCT06713421
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2024-12-01
Completion date: 2025-09-01
Sponsor: Changhai Hospital
Collaborators: Fujian Provincial Hospital; Huashan Hospital; The Second Affiliated Hospital of Harbin Medical University; First Affiliated Hospital of Harbin Medical University; Red Cross Hospital, Hangzhou, China; The Affiliated Hospital of Inner Mongolia Medical University; Yuebei People's Hospital; Longgang District People's Hospital of Shenzhen; Huadu District People's Hospital of Guangzhou; Liaocheng People's Hospital; Qilu Hospital of Shandong University; The Second Affiliated Hospital of Shandong First Medical University; Anqing Municipal Hospital; Jiujiang No.1 People's Hospital; Kunshan Hospital of Traditional Chinese Medicine; Nanjing Gaochun People's Hospital; Taizhou First People's Hospital; Hengshui People's Hospital; Affiliated Hospital of Hebei University; Second Affiliated Hospital of Xi'an Jiaotong University; Taihe Hospital; ZhuZhou Central Hospital; The Second Affiliated Hospital of Kunming Medical University; First Affiliated Hospital of Kunming Medical University; Subei People's Hospital of Jiangsu Province; The Affiliated Hospital Of Southwest Medical University; The Second Affiliated Hospital of Chongqing Medical University; Loudi Central Hospital; Beijing Tiantan Hospital; Peking Union Medical College Hospital; First People's Hospital of Hangzhou; Zhejiang Provincial People's Hospital; Jining Medical University; Ningbo Medical Center Lihuili Hospital; Zhoushan Hospital, Zhejiang; General Hospital of Ningxia Medical University; Yunnan Cancer Hospital; Xinghua City People's Hospital; Beijing Friendship Hospital, Captial Medical University; Beijing Chao-Yang Hospital, Captial Medical University; The People's Hospital of JiangMen; The First People's Hospital of TianMen in Hubei Province; The First Affilated Hospital of the Medical College, Shihezi University
Conditions: Esophageal Cancer; Gastric Cancer
Interventions: Dimethicone+Pronase; Dimethicone; with Postural Exercise; without Postural Exercise.
Locations: Changhai hosipital
Countries: China
Enrollment: 3000
Age range: 18 Years - 70 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

1. Male or female aged ≥18 years and ≤70 years;
2. Voluntarily participate in the trial and sign the informed consent.

Exclusion Criteria:

1. active gastrointestinal bleeding;
2. esophageal stricture, complete pyloric obstruction and gastroparesis caused by various reasons;
3. diagnosed malignant tumors of the upper digestive tract;
4. a history of upper gastrointestinal surgery;
5. severe heart, liver and kidney diseases, and the doctor judges that it is not suitable for painless gastroscopy;
6. serious mental illness;
7. pregnancy or breastfeeding;
8. an allergy to pronase or dimeticone;
9. current participation in other clinical trials and in the follow-up or drug washout period;
10. patients considered by the investigator to be unsuitable for this study

Outcomes:
Mucosal Cleanliness Scores