Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dimethicone | Drug | — | UNRESOLVED |
| Dimethicone+Pronase | Drug | — | UNRESOLVED |
| without Postural Exercise. | Behavioral | — | UNRESOLVED |
| with Postural Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A1:Dimeticone+Pronase+Postural Exercise 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.
- interventionNames
- Drug: Dimethicone+Pronase
- Behavioral: with Postural Exercise
- type
- EXPERIMENTAL
- label
- A2:Dimeticone+Pronase 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.
- interventionNames
- Drug: Dimethicone+Pronase
- Behavioral: without Postural Exercise.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available