NCT06713421Recruiting
Effect of Premedication With Pronase on 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
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3000 (estimated)
- First submitted
- 9 Nov 2024
- Start date
- 1 Dec 2024
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- Changhai Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06713421
What you commit to
- Study type: Interventional
- Planned participants: 3000
- From 1 Dec 2024 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- current participation in other clinical trials and in the follow-up or drug washout period;
Other illness
- active gastrointestinal bleeding;
- 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;
- an allergy to pronase or dimeticone;
Other
- esophageal stricture, complete pyloric obstruction and gastroparesis caused by various reasons;
- pregnancy or breastfeeding;
- patients considered by the investigator to be unsuitable for this study
Who the study is looking for
- Male or female aged ≥18 years and ≤70 years;
- Voluntarily participate in the trial and sign the informed consent.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Changhai hosipital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.