Effect of Premedication With Pronase on Mucosal Cleanliness During EGD

Not Applicable

Recruiting

• Conditions: Esophageal Cancer; Gastric Cancer
• Interventions: Drug: Dimethicone+Pronase; Drug: Dimethicone; Behavioral: with Postural Exercise; Behavioral: without Postural Exercise.

• Registration Number: NCT06713421
• Lead Sponsor: Changhai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-09
• Study First Submitted QC: 2024-11-27
• Study Start: 2024-12-01
• Study First Posted: 2024-12-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-22
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
A1:Dimeticone+Pronase+Postural Exercise group	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. Then the patients are asked to take a 3-minute postural exercise.
A1:Dimeticone+Pronase+Postural Exercise group	with Postural Exercise	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.
A2:Dimeticone+Pronase group	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. Then the patients sit quietly awaiting examination.
A2:Dimeticone+Pronase group	without Postural Exercise.	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.
B1:Dimeticone+Postural Exercise group	Dimethicone	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.
B1:Dimeticone+Postural Exercise group	with Postural Exercise	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.
B2:Dimeticone group	Dimethicone	Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients sit quietly awaiting examination.
B2:Dimeticone group	without Postural Exercise.	Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients sit quietly awaiting examination.

Primary Outcome Measures

Name	Time	Method
Mucosal Cleanliness Scores	Through study completion, an average of 1 year	The upper digestive tract is divided into 9 anatomical parts, including esophagus, squamocolumnar junction, middle-upper gastric body, lower gastric body, gastric antrum, duodenal bulb, duodenal descending, gastric angulus and gastric fundus.; The mucosal cleanliness score of each segment is classified as 0-3. Score0: any solid food, blood or blood clots, or other content that could not be suctioned or washed, or an obstruction that prevented adequate visualization of the majority of an anatomical area.; Score 1: mucus, bubbles, liquid content, and blood that required suctioning AND/OR washing.; Score 2: nonadherent liquid content or blood that required ONLY suctioning but NOT washing.; Score 3: entire mucosa well seen without the need for suctioning or washing. The sum of the mucosal cleanliness scores for the above mentioned 9 locations ranges from 0 to 27.

Secondary Outcome Measures

Name	Time	Method
Procedure Time	Through study completion, an average of 1 year	The procedure time of EGD is defined as the time taken from the entry of EGD into the esophagus to the withdrawal of the EGD.
The Detection Rate of Diminutive Lesions	Through study completion, an average of 1 year	The detection rate of diminutive lesions means the proportion of patients with diminutive lesions \<5 mm.
Safety of antifoam/mucus agents	Through study completion, an average of 1 year	Any adverse event including gag reflex and hypoxemia during EGD examination need to be recorded.

Trial Locations

Locations (1)

Changhai hosipital; 🇨🇳 Shanghai, China