Patients after gastric ESD surgery
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age 20-70 years, gender is not limited; 2) meet the surgical indications for endoscopic gastricendoscopic submucosal dissection (ESD) treatment; 3) Normal coagulation function; 4) Subjects who fully understand the content of the trial, participate in the trial voluntarily and are able to complete the trial process, and sign an informed consent form. 4) Subjects who fully understand the content of the trial, are willing to participate in the trial and are able to complete the trial process, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Patients who have undergone endoscopic total mesotheliotomy; 2) patients with diabetes mellitus, cirrhosis of the liver (coagulation abnormalities), blood disorders causing coagulation abnormalities diseases, and autoimmune diseases that may cause delayed healing of ulcers; 3) patients who have used antithrombotic drugs (aspirin, clopidogrel, heparin, etc.), NSAIDs, and other medications within 4 weeks prior to surgery, and the need to resume the use of these medications in the immediate postoperative period; 4) History of gastric surgery; 5) Serious complications after gastric ESD or failure to achieve curative resection requiring additional surgery; 6) pregnant and lactating women, and those who may conceive or prepare for pregnancy during the clinical trial; 7) those who have had an allergic reaction to keplasen hydrochloride; 8) Incompetent, unable to express their complaints correctly, such as mental illness, severe neurological disorders, and unable to cooperate with the trial. 9) Participating in other drugs/devices clinical studies within 3 months prior to enrollment and using the test drugs/devices. 10) Any other person who, in the opinion of the investigator, is not suitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients confirmed by endoscopic examination to have ulcer healing 8 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients confirmed by endoscopic examination to have ulcer healing 4 weeks after surgery;The incidence of delayed bleeding within 4 weeks after surgery;The incidence of delayed bleeding within 8 weeks after surgery; | — |
Countries
China
Contacts
Shengjing Hospital of China Medical University