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| Name | Class |
|---|---|
| Fujian Provincial Hospital | OTHER |
| Huashan Hospital | OTHER |
| The Second Affiliated Hospital of Harbin Medical University | OTHER |
| First Affiliated Hospital of Harbin Medical University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethicone+Pronase | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 1 year |
| The Detection Rate of Diminutive Lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luowei Wang, MD | Contact | 13901833088 | wangluoweimd@126.com | |
| Lei Xin, MD | Contact | 13817318134 | aip_xin@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Luowei Wang, MD | Changhai hosipital, Shanghai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai hosipital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C501844 | dimethicone |
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| OTHER |
| Red Cross Hospital, Hangzhou, China | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| Yuebei People's Hospital | OTHER |
| Longgang District People's Hospital of Shenzhen | OTHER |
| Huadu District People's Hospital of Guangzhou | OTHER |
| Liaocheng People's Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| The Second Affiliated Hospital of Shandong First Medical University | OTHER |
| Anqing Municipal Hospital | OTHER |
| Jiujiang No.1 People's Hospital | OTHER |
| Kunshan Hospital of Traditional Chinese Medicine | OTHER |
| Nanjing Gaochun People's Hospital | OTHER |
| Taizhou First People's Hospital | OTHER |
| Hengshui People's Hospital | OTHER |
| Affiliated Hospital of Hebei University | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Taihe Hospital | OTHER |
| ZhuZhou Central Hospital | OTHER |
| The Second Affiliated Hospital of Kunming Medical University | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| Subei People's Hospital of Jiangsu Province | OTHER |
| The Affiliated Hospital Of Southwest Medical University | OTHER |
| The Second Affiliated Hospital of Chongqing Medical University | OTHER |
| Loudi Central Hospital | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Peking Union Medical College Hospital | OTHER |
| First People's Hospital of Hangzhou | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Jining Medical University | OTHER |
| Ningbo Medical Center Lihuili Hospital | OTHER_GOV |
| Zhoushan Hospital, Zhejiang | UNKNOWN |
| General Hospital of Ningxia Medical University | OTHER |
| Yunnan Cancer Hospital | OTHER |
| Xinghua City People's Hospital | UNKNOWN |
| Beijing Friendship Hospital, Captial Medical University | UNKNOWN |
| Beijing Chao-Yang Hospital, Captial Medical University | UNKNOWN |
| The People's Hospital of JiangMen | UNKNOWN |
| The First People's Hospital of TianMen in Hubei Province | UNKNOWN |
| The First Affilated Hospital of the Medical College, Shihezi University | OTHER |
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| Dimethicone | Drug | Approximately 15-20 minutes before EGD, patients orally receive 50mL of warm water containing 5g dimethicone powder. |
|
| with Postural Exercise | Behavioral | 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. | Behavioral | After the premedication is administered orally approximately 15-20 minutes before EGD, patients sit quietly awaiting examination. |
|
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 | Any adverse event including gag reflex and hypoxemia during EGD examination need to be recorded. | Through study completion, an average of 1 year |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |