Clinical trial NCT06713421: Effect of Premedication With Pronase on Mucosal Cleanliness During EGD
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: EGD
Pronase
Postural exercise
Mucosal cleanliness
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Fujian Provincial Hospital
name: Huashan Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: First Affiliated Hospital of Harbin Medical University
name: Red Cross Hospital, Hangzhou, China
name: The Affiliated Hospital of Inner Mongolia Medical University
name: Yuebei People's Hospital
name: Longgang District People's Hospital of Shenzhen
name: Huadu District People's Hospital of Guangzhou
name: Liaocheng People's Hospital
name: Qilu Hospital of Shandong University
name: The Second Affiliated Hospital of Shandong First Medical University
name: Anqing Municipal Hospital
name: Jiujiang No.1 People's Hospital
name: Kunshan Hospital of Traditional Chinese Medicine
name: Nanjing Gaochun People's Hospital
name: Taizhou First People's Hospital
name: Hengshui People's Hospital
name: Affiliated Hospital of Hebei University
name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Taihe Hospital
name: ZhuZhou Central Hospital
name: The Second Affiliated Hospital of Kunming Medical University
name: First Affiliated Hospital of Kunming Medical University
name: Subei People's Hospital of Jiangsu Province
name: The Affiliated Hospital Of Southwest Medical University
name: The Second Affiliated Hospital of Chongqing Medical University
name: Loudi Central Hospital
name: Beijing Tiantan Hospital
name: Peking Union Medical College Hospital
name: The First People's Hospital of Lin'an District, Hangzhou
name: Zhejiang Provincial People's Hospital
name: Jining Medical University
name: Ningbo Medical Center Lihuili Hospital
name: Zhoushan Hospital, Zhejiang
name: General Hospital of Ningxia Medical University
name: Yunnan Cancer Hospital
name: Xinghua City People's Hospital
name: Beijing Friendship Hospital, Captial Medical University
name: Beijing Chao-Yang Hospital, Captial Medical University
name: The People's Hospital of JiangMen
name: The First People's Hospital of TianMen in Hubei Province
name: THE FIRST AFFILIATED HOSPITAL OF SHIHEZI UNIVERSITY
First posted: 2024-12-03
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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

Primary outcomes:
measure: Mucosal Cleanliness Scores
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Procedure Time
timeFrame: Through study completion, an average of 1 year
measure: The Detection Rate of Diminutive Lesions
timeFrame: Through study completion, an average of 1 year
measure: Safety of antifoam/mucus agents
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hosipital
Study officials:
affiliation: Changhai hosipital, Shanghai
name: Luowei Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: