Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

Naval Military Medical University

Status: Enrolling

Conditions: Gastric Cancer; Esophageal Cancer

Treatments: Behavioral: without Postural Exercise.; Drug: Dimethicone+Pronase; Behavioral: with Postural Exercise; Drug: Dimethicone

Study type: Interventional

Funder types: Other

Identifiers

NCT06713421

EPPMC

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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3,000 participants in 4 patient groups

A1:Dimeticone+Pronase+Postural Exercise group

Experimental group

Description:

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.

Treatment:

Behavioral: with Postural Exercise

Drug: Dimethicone+Pronase

A2:Dimeticone+Pronase group

Experimental group

Description:

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.

Treatment:

Drug: Dimethicone+Pronase

Behavioral: without Postural Exercise.

B1:Dimeticone+Postural Exercise group

Active Comparator group

Description:

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.

Treatment:

Behavioral: with Postural Exercise

Drug: Dimethicone

B2:Dimeticone group

Active Comparator group

Description:

Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients sit quietly awaiting examination.

Treatment:

Drug: Dimethicone

Behavioral: without Postural Exercise.