Early gastric cancer
Conditions
Interventions
Experimental group:After surgery, sucralfate suspension gel covered ulcer surface + sulfoaluminium suspension gel + esomeprazole sodium for injection + esomeprazole magnesium enteric-coated tablet
Control group:Rebapide tablets + Esomeprazole sodium for injection + esomeprazole magnesium enteric-coated tablets
Sponsors
The First Affiliated Hospital of Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 79 Years
Inclusion criteria
Inclusion criteria: 1.Subjects agreeing to participate in the study voluntarily sign a written informed consent form approved by the ETHICS Committee prior to the commencement of any study procedure; 2.Subjects who understand and comply with protocol requirements and agree to participate in all study visits; 3.Aged 18 to 80 years old (not include 80 years), hospitalized cases, male and female; 4.Meeting the indications of ESD surgery: (1)Non-invasive tumor (low-grade to high-grade intraepithelial neoplasia); (2)Differentiated intramucosal carcinoma without ulcer; (3)Differentiated intramucosal carcinoma with ulceration, maximum diameter <=3cm; (4)Undifferentiated intramucosal carcinoma, maximum diameter <=2cm. 5.Normal coagulation function; 6.Subjects who can accept upper gastrointestinal endoscopy and treatment.
Exclusion criteria
Exclusion criteria: 1.Participated in other clinical studies during the 4 weeks prior to first taking the study drug, except for the following two conditions: (1)The study the subject is participating in or has participated in is non-interventional (such as observational study or questionnaire study), and does not interfere with the efficacy and safety evaluation in the current study as determined by the investigator; (2)Subjects signed informed consent to participate in another study, but withdrew from the study before starting any study medication. 2.Pregnant and lactating women, or women with birth plans during the study period; 3.Subjects who are allergic to the active ingredients or excipients of drugs used in this study (esomeprazole sodium for injection, esomeprazole magnesium enteric-coated tablets, sulfoaluminium suspension gel, and ribapide tablets); 4.Subjects with bipolar disorder, somatoform disorder, personality disorder, schizophrenia or other mental disorders; 5.Subjects with Zhuo-Ai syndrome; 6.Subjects with a history of upper gastrointestinal surgery (especially prior surgical, EMR, or ESD treatment); 7.Except for drugs involved in this study, subjects are required to take other drugs that can affect ulcer wound healing (including corticosteroids, rehabilitation fluid, bismuth, misoprostol, thioglycoptide, tipreidone, etc.) during the study period; 8.Subjects with poor physical fitness complicated with serious cardiovascular diseases, respiratory, blood, liver and kidney diseases, and other serious diseases of digestive tract (such as Crohn's disease, ulcerative colitis, etc.); 9.Abnormal results of any of the following laboratory tests at screening time: (1)AST, ALT > 2 times normal upper limit (ULN); (2)Total bilirubin > 2 times ULN; (3)Creatinine > 2 times ULN; (4)Platelet 1.5 TIMES ULN. 10.The subjects' electrocardiogram (ECG) showed the following abnormalities: severe arrhythmia, multi-focal ventricular presystole (PVC), second degree or higher atrioventricular block, etc.; 11.The investigator considers that there are any other reasons why the subject is not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ulcer area reduction rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ulcer healing rate;Symptom assessment based on the subject's diary;Delayed bleeding rate and readmission rate;Other indicators; | — |
Countries
China
Contacts
Public ContactZhang Guoxin
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed