NCT06713421

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Esophageal Cancer
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Dimethicone+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.
DRUG	Dimethicone	Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.
BEHAVIORAL	with Postural Exercise	After the premedication is administered orally approximately 15-20 minutes before EGD, patients are asked to take a 3-minute postural exercise.
BEHAVIORAL	without Postural Exercise.	After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2024-12-03
• Last updated: 2025-02-25

Locations

1 site across 1 country: China