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| Name | Class |
|---|---|
| First Affiliated Hospital of Jinan University | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Maoming People's Hospital | OTHER |
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The purpose of this clinical trial is to find out the effectiveness of voronasan in combination with aluminum phosphate gel in the treatment of post-operative ESD ulcers. It will also find out about the safety of vunorasan in combination with aluminum phosphate gel. The main questions it aims to answer are:
Participants will:
Intravenous lansoprazole 1-3 days after ESD and oral voronasan combined with aluminum phosphate gel or esomeprazole combined with aluminum phosphate gel 3-56 days after ESD.
Record their symptoms, endoscopic ulcer grading, ulcer size and Calculate ulcer healing rate at weeks 2 and 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Vonorasan、tablet、20mg、qd、Days 3 to 56 |
|
| Control group | Active Comparator | Esomeprazole 、tablet、20mg、Days 3 to 56 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vonoprazan | Drug | oral drug 3-56 days after ESD. |
| |
| Esomeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ulcer reduction | Ulcer area = maximum diameter of the ulcer * perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = [(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer]*100% The rate of ulcer reduction at 8 weeks = [ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer]*100% Ulcer area = maximum diameter of the ulcer * perpendicular line of the maximum diameter (mm2) The rate of ulcer reduction at 2 weeks = [(area of the initial ulcer - area of the ulcer at 2 weeks)/area of the initial ulcer]*100% The rate of ulcer reduction at 8 weeks = [ (area of the initial ulcer - area of the ulcer at 8 weeks)/area of the initial ulcer]*100% | 2nd and 8th week post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Size of ulcer | Ulcer area = maximum diameter of the ulcer * perpendicular line of the maximum diameter (mm2) | 2nd and 8th week post-dose |
| Rate of ulcer healing | Healing rate = number of cases with scarring/total number of cases × 100 per cent |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shicai Ye, PhD | Contact | +86 133 6070 9925 | caizi23@126.com | |
| Yuping Yang, PhD | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Jinan University | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D013276 | Stomach Ulcer |
| ID | Term |
|---|---|
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| C552956 | 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine |
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Yellow River Sanmenxia hospital |
| UNKNOWN |
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| Drug |
oral drug 3-56 days after ESD. |
|
| 2nd and 8th week post-dose |
| Rate of bumpy | Rate of bumpy= number of cases that have occurred/total number of cases × 100 per cent | 2nd and 8th week post-dose |
| Quality of ulcer healing | Scoring using the Ulcer Healing Scoring Scale，the highest score is 3 and the lowest is 1, with higher scores indicating better ulcer healing | 2nd and 8th week post-dose |
| Rate of delayed hemorrhage | Rate of delayed hemorrhage=Number of haemorrhages/total | 2th week post-dose |
| Postoperative symptom relief rate | Number of persons in remission/total | 2th week post-dose |
| The First Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China |
|
| Maoming People's Hospital | Maoming | Guangdong | China |
| Yellow River Sanmenxia Hospital | Sanmenxia | Henan | China |
|
| D004066 |
| Digestive System Diseases |
| D013272 | Stomach Diseases |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |