Esophageal CancerNCT06713421
Effect of Premedication With Pronase on Mucosal Cleanliness During EGD
A study testing Dimethicone+Pronase, Dimethicone and with Postural Exercise in people with Esophageal Cancer and Gastric Cancer, run by Changhai Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer
- What is being tested?
- Dimethicone+Pronase, Dimethicone and with Postural Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years and ≤70 years;
- Voluntarily participate in the trial and sign the informed consent.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Changhai hosipital
Shanghai
Chu Chu, 13817318134, chuchu19920818@163.com
About this study
Official title: 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.
- Conditions
- Esophageal Cancer, Gastric Cancer
- Being tested
- Dimethicone+Pronase, Dimethicone, with Postural Exercise, without Postural Exercise.
- Keywords
- EGD, Pronase, Postural exercise, Mucosal cleanliness
- Medical subject headings
- Esophageal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethicone+PronaseDrug
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.
DimethiconeDrug
Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder.
with Postural ExerciseBehavioural
After the premedication is administered orally approximately 15-20 minutes before EGD, patients are asked to take a 3-minute postural exercise.
without Postural Exercise.Behavioural
After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination.
| Study group | Role | What they receive |
|---|---|---|
| A1:Dimeticone+Pronase+Postural Exercise group | Experimental | 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. Receives: Drug: Dimethicone+Pronase; Behavioral: with Postural Exercise |
| A2:Dimeticone+Pronase group | Experimental | 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. Receives: Drug: Dimethicone+Pronase; Behavioral: without Postural Exercise. |
| B1:Dimeticone+Postural Exercise group | Active comparator | 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. Receives: Drug: Dimethicone; Behavioral: with Postural Exercise |
| B2:Dimeticone group | Active comparator | Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. Then the patients sit quietly awaiting examination. Receives: Drug: Dimethicone; Behavioral: without Postural Exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucosal Cleanliness Scores
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Procedure Time
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.
Measured: Through study completion, an average of 1 year
The Detection Rate of Diminutive Lesions
The detection rate of diminutive lesions means the proportion of patients with diminutive lesions \<5 mm.
Measured: Through study completion, an average of 1 year
Safety of antifoam/mucus agents
Any adverse event including gag reflex and hypoxemia during EGD examination need to be recorded.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Provincial Hospital, Huashan Hospital, The Second Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Harbin Medical University, Red Cross Hospital, Hangzhou, China, The Affiliated Hospital of Inner Mongolia Medical University, Yuebei People's Hospital, Longgang District People's Hospital of Shenzhen, Huadu District People's Hospital of Guangzhou, Liaocheng People's Hospital, Qilu Hospital of Shandong University, The Second Affiliated Hospital of Shandong First Medical University, Anqing Municipal Hospital, Jiujiang No.1 People's Hospital, Kunshan Hospital of Traditional Chinese Medicine, Nanjing Gaochun People's Hospital, Taizhou First People's Hospital, Hengshui People's Hospital, Affiliated Hospital of Hebei University, Second Affiliated Hospital of Xi'an Jiaotong University, Taihe Hospital, ZhuZhou Central Hospital, The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Kunming Medical University, Subei People's Hospital of Jiangsu Province, The Affiliated Hospital Of Southwest Medical University, The Second Affiliated Hospital of Chongqing Medical University, Loudi Central Hospital, Beijing Tiantan Hospital, Peking Union Medical College Hospital, First People's Hospital of Hangzhou, Zhejiang Provincial People's Hospital, Jining Medical University, Ningbo Medical Center Lihuili Hospital, Zhoushan Hospital, Zhejiang, General Hospital of Ningxia Medical University, Yunnan Cancer Hospital, Xinghua City People's Hospital, Beijing Friendship Hospital, Captial Medical University, Beijing Chao-Yang Hospital, Captial Medical University, The People's Hospital of JiangMen, The First People's Hospital of TianMen in Hubei Province, The First Affiliated Hospital of Shihezi University
- Responsible party
- Principal investigator, Luowei Wang, MD, Changhai Hospital
- Investigators
- Luowei Wang, MD, Principal investigator, Changhai hosipital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713421
- Sponsor's protocol ID
- EPPMC
- Status last verified
- Feb 2025
- First submitted
- 9 Nov 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06713421
- Acronym / sponsor ID
- EPPMC
- Conditions
- Esophageal Cancer, Gastric Cancer
- Keywords
- EGD, Pronase, Postural exercise, Mucosal cleanliness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Fujian Provincial Hospital, Huashan Hospital, The Second Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Harbin Medical University, Red Cross Hospital, Hangzhou, China, The Affiliated Hospital of Inner Mongolia Medical University, Yuebei People's Hospital, Longgang District People's Hospital of Shenzhen, Huadu District People's Hospital of Guangzhou, Liaocheng People's Hospital, Qilu Hospital of Shandong University, The Second Affiliated Hospital of Shandong First Medical University, Anqing Municipal Hospital, Jiujiang No.1 People's Hospital, Kunshan Hospital of Traditional Chinese Medicine, Nanjing Gaochun People's Hospital, Taizhou First People's Hospital, Hengshui People's Hospital, Affiliated Hospital of Hebei University, Second Affiliated Hospital of Xi'an Jiaotong University, Taihe Hospital, ZhuZhou Central Hospital, The Second Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Kunming Medical University, Subei People's Hospital of Jiangsu Province, The Affiliated Hospital Of Southwest Medical University, The Second Affiliated Hospital of Chongqing Medical University, Loudi Central Hospital, Beijing Tiantan Hospital, Peking Union Medical College Hospital, First People's Hospital of Hangzhou, Zhejiang Provincial People's Hospital, Jining Medical University, Ningbo Medical Center Lihuili Hospital, Zhoushan Hospital, Zhejiang, General Hospital of Ningxia Medical University, Yunnan Cancer Hospital, Xinghua City People's Hospital, Beijing Friendship Hospital, Captial Medical University, Beijing Chao-Yang Hospital, Captial Medical University, The People's Hospital of JiangMen, The First People's Hospital of TianMen in Hubei Province, The First Affiliated Hospital of Shihezi University
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1:Dimeticone+Pronase+Postural Exercise group | Experimental | Drug: Dimethicone+Pronase, Behavioral: with Postural ExerciseApproximately 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 | Experimental | Drug: Dimethicone+Pronase, Behavioral: 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 | Active comparator | Drug: Dimethicone, Behavioral: with Postural ExerciseApproximately 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 | Active comparator | Drug: Dimethicone, Behavioral: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged ≥18 years and ≤70 years;
- Voluntarily participate in the trial and sign the informed consent.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethicone+PronaseApproximately 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 | A1:Dimeticone+Pronase+Postural Exercise group, A2:Dimeticone+Pronase group |
| DimethiconeApproximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. | Drug | B1:Dimeticone+Postural Exercise group, B2:Dimeticone group |
| with Postural ExerciseAfter the premedication is administered orally approximately 15-20 minutes before EGD, patients are asked to take a 3-minute postural exercise. | Behavioural | A1:Dimeticone+Pronase+Postural Exercise group, B1:Dimeticone+Postural Exercise group |
| without Postural Exercise.After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination. | Behavioural | A2:Dimeticone+Pronase group, B2:Dimeticone group |
Primary outcome
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.
3 secondary outcomes
Procedure Time
Time frame: Through study completion, an average of 1 year
The Detection Rate of Diminutive Lesions
Time frame: Through study completion, an average of 1 year
Safety of antifoam/mucus agents
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luowei Wang, MD principal investigator
Changhai hosipital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dimethicone+Pronase, Dimethicone and with Postural Exercise in people with Esophageal Cancer and Gastric Cancer, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luowei Wang, MD (13901833088, wangluoweimd@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucosal Cleanliness Scores (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.