Treatment of wounds after gastric ESD surgery
Conditions
Interventions
Treatment group :tissue repair medical glue combined with spray gun
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18~80 years old (including cut-off value); (2) Patients who require gastric ESD treatment due to precancerous lesions or early gastric cancer, etc., meet the indications for gastric ESD, and the diameter of the lesion is within the range of 1.5~3cm (including the cut-off value)*; (3) Those who can tolerate and cooperate with endoscopy; (4) Those who voluntarily sign the informed consent form. *Lesion diameter: The length axis of the lesion assessed by the width of the opening mouth of the biopsy forceps under endoscopy before surgery shall prevail.
Exclusion criteria
Exclusion criteria: (1) Those who have participated in other clinical trials within 90 daysbefore the start of this trial; (2) Those who have received or plan to receive radiotherapy or chemotherapy during the trial within 90 days* before the start of this trial; (3) Patients with a history of other malignant tumors (except carcinoma in situ and curable malignant tumors); (4) Patients with lymph node metastasis or distant metastasis; (5) Patients with symptoms such as severe cardiopulmonary disease, allergic disease, uncorrected infection or other high-risk conditions that are not suitable for gastric ESD assessed by the investigator; (6) Patients who need to take hormonal drugs, NSAIDs or immunosuppressants for a long time; (7) Patients with severe anemia: hemoglobin concentration is less than 60g/L, and the investigator thinks it is clinically significant; (8) Patients with coagulation dysfunction: abnormal coagulation function indicators (prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR), fibrinogen (FIB)), and those who are considered clinically significant by the investigator; (9) Abnormal liver function: ALT and AST exceed 3 times the normal value; Bilirubin exceeds 2 times the normal range value and is judged to be clinically significant by the investigator; (10) Abnormal renal function: creatinine, urea nitrogen/urea exceeding the normal range value and judged by the investigator to be clinically significant; (11) Those who take antithrombotic drugs (antiplatelet drugs, thrombolytic drugs, anticoagulant drugs) within 7 days before the start of surgery; (12) Pregnant or lactating women; (13) Those who are allergic to human blood albumin and anesthetics; (14) Those with mental illness who cannot cooperate with endoscopic examination; (15) Muscle propria damage in the test area after gastric ESD reaches MPI-p grade as follows: MPI-p grade is muscle propria perforation, MPI-pa grade is muscle propria perforation, which can be successfully repaired under endoscopy; MPI-pb grade is a muscle propria injury that cannot be treated endoscopically and needs to be treated surgically. (16) Those who are difficult to apply the investigational product or have difficulty observing the wound position with an endoscope; (17) Those who are considered inappropriate by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| S-phase acquisition rate 4 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Distribution of each stage 4 weeks after surgery;The wound closure rate at 4 weeks post-operation;the rate of delayed bleeding;Pain assessment;Effective rate of spraying gun; | — |
Countries
China
Contacts
Public ContactLi Zhaoshen
Shanghai Changhai Hospital
Outcome results
None listed