RecruitingNot ApplicableNCT06713421

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


Sponsor

Changhai Hospital

Enrollment

3,000 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether taking a medication (pronase) before an upper endoscopy (a camera exam of the throat and stomach) helps clear mucus and improve the doctor's view during the procedure. **You may be eligible if...** - You are between 18 and 70 years old - You are scheduled for an upper endoscopy - You are willing to participate and have signed the consent form **You may NOT be eligible if...** - You have active bleeding in your digestive tract - You have a narrowing in your esophagus, a stomach outlet blockage, or gastroparesis (slow stomach emptying) - You have been diagnosed with cancer of the upper digestive tract - You have had previous surgery on your upper digestive tract - You have severe heart, liver, or kidney disease - You have a serious mental illness - You are pregnant or breastfeeding - You are allergic to pronase or simethicone - You are currently enrolled in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDimethicone+Pronase

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.

DRUGDimethicone

Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.

BEHAVIORALwith Postural Exercise

After the premedication is administered orally approximately 15-20 minutes before EGD, patients are asked to take a 3-minute postural exercise.

BEHAVIORALwithout Postural Exercise.

After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination.


Locations(1)

Changhai hosipital

Shanghai, China

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NCT06713421


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