Effect of Premedication With Pronase on Mucosal Cleanliness During EGD
February 22, 2025 updated by: Luowei Wang, MD, Changhai Hospital
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
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
3000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Luowei Wang, MD
- Phone Number: 13901833088
- Email: wangluoweimd@126.com
Study Contact Backup
- Name: Lei Xin, MD
- Phone Number: 13817318134
- Email: aip_xin@163.com
Study Locations
-
-
-
Shanghai, China
- Recruiting
- Changhai hosipital
-
Contact:
- Chu Chu
- Phone Number: 13817318134
- Email: chuchu19920818@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male or female aged ≥18 years and ≤70 years;
- Voluntarily participate in the trial and sign the informed consent.
Exclusion Criteria:
- active gastrointestinal bleeding;
- esophageal stricture, complete pyloric obstruction and gastroparesis caused by various reasons;
- diagnosed malignant tumors of the upper digestive tract;
- a history of upper gastrointestinal surgery;
- severe heart, liver and kidney diseases, and the doctor judges that it is not suitable for painless gastroscopy;
- serious mental illness;
- pregnancy or breastfeeding;
- an allergy to pronase or dimeticone;
- current participation in other clinical trials and in the follow-up or drug washout period;
- patients considered by the investigator to be unsuitable for this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A1:Dimeticone+Pronase+Postural Exercise group
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.
|
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.
After the premedication is administered orally approximately 15-20 minutes before EGD, patients are asked to take a 3-minute postural exercise.
|
|
Experimental: A2:Dimeticone+Pronase group
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.
|
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.
After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination.
|
|
Active Comparator: B1:Dimeticone+Postural Exercise group
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.
|
After the premedication is administered orally approximately 15-20 minutes before EGD, patients are asked to take a 3-minute postural exercise.
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.
|
|
Active Comparator: B2:Dimeticone group
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.
Then the patients sit quietly awaiting examination.
|
After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination.
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mucosal Cleanliness Scores
Time Frame: 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. |
Through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Procedure Time
Time Frame: 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.
|
Through study completion, an average of 1 year
|
|
The Detection Rate of Diminutive Lesions
Time Frame: Through study completion, an average of 1 year
|
The detection rate of diminutive lesions means the proportion of patients with diminutive lesions <5 mm.
|
Through study completion, an average of 1 year
|
|
Safety of antifoam/mucus agents
Time Frame: Through study completion, an average of 1 year
|
Any adverse event including gag reflex and hypoxemia during EGD examination need to be recorded.
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Luowei Wang, MD, Changhai hosipital, Shanghai
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
November 9, 2024
First Submitted That Met QC Criteria
November 27, 2024
First Posted (Actual)
December 3, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 22, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EPPMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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