Using Pronase to Improve Mucosal Cleanliness During EGD
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
This study is testing whether using a medication called pronase along with some exercises can help make it easier to see inside the esophagus and stomach during an EGD for patients with esophageal and gastric cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06713421 on ClinicalTrials.gov |
What this trial studies
This study investigates the effect of premedication with pronase and dimethicone on mucosal cleanliness during esophagogastroduodenoscopy (EGD) in patients with esophageal and gastric cancer. It aims to determine whether adding postural exercises enhances the effectiveness of these medications in improving visibility during the procedure. The study will compare different intervention groups to assess the impact on mucosal cleanliness and the potential for better detection of lesions. The findings could provide insights into optimizing EGD procedures for better diagnostic outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 who are undergoing EGD for suspected upper gastrointestinal issues.
Not a fit: Patients with active gastrointestinal bleeding, severe comorbidities, or a history of upper gastrointestinal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved detection rates of upper gastrointestinal lesions, reducing the risk of missed diagnoses in patients.
How similar studies have performed: Previous studies have suggested improvements in mucosal cleanliness with similar premedication approaches, but this study aims to provide more robust evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Changhai hosipital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Luowei Wang, MD — Changhai hosipital, Shanghai
- Study coordinator: Luowei Wang, MD
- Email: wangluoweimd@126.com
- Phone: 13901833088
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.