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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Male or female aged ≥18 years and ≤70 years;

• Voluntarily participate in the trial and sign the informed consent.

Locations
Other Locations
China
Changhai hosipital
RECRUITING
Shanghai
Contact Information
Primary
Luowei Wang, MD
wangluoweimd@126.com
13901833088
Backup
Lei Xin, MD
aip_xin@163.com
13817318134
Time Frame
Start Date: 2024-12-01
Estimated Completion Date: 2025-09-01
Participants
Target number of participants: 3000
Treatments
Experimental: 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.
Experimental: 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.
Active_comparator: 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.
Active_comparator: 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.
Sponsors
Collaborators: Yuebei People's Hospital, Liaocheng People's Hospital, ZhuZhou Central Hospital, Fujian Provincial Hospital, Peking Union Medical College Hospital, Hengshui People's Hospital, Ningbo Medical Center Lihuili Hospital, Nanjing Gaochun People's Hospital, Huadu District People's Hospital of Guangzhou, First Affiliated Hospital of Kunming Medical University, Taizhou First People's Hospital, Beijing Friendship Hospital, Captial Medical University, Loudi Central Hospital, General Hospital of Ningxia Medical University, Qilu Hospital of Shandong University, The Affiliated Hospital of Inner Mongolia Medical University, Subei People's Hospital of Jiangsu Province, The First People's Hospital of Lin'an District, Hangzhou, The Affiliated Hospital Of Southwest Medical University, First Affiliated Hospital of Harbin Medical University, Jiujiang No.1 People's Hospital, Taihe Hospital, The First People's Hospital of TianMen in Hubei Province, Anqing Municipal Hospital, Zhoushan Hospital, Zhejiang, Affiliated Hospital of Hebei University, The Second Affiliated Hospital of Shandong First Medical University, THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY, Yunnan Cancer Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Harbin Medical University, Beijing Chao-Yang Hospital, Captial Medical University, Jining Medical University, Huashan Hospital, Beijing Tiantan Hospital, The Second Affiliated Hospital of Chongqing Medical University, The People's Hospital of JiangMen, Xinghua City People's Hospital, Kunshan Hospital of Traditional Chinese Medicine, The Second Affiliated Hospital of Kunming Medical University, Red Cross Hospital, Hangzhou, China, Longgang District People's Hospital of Shenzhen, Zhejiang Provincial People's Hospital
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov