Superficial gastric tumor superficial gastric tumor, endoscopic submucosal dissection
Conditions
Interventions
1. Flushing Group
The procedure was performed according to the fol
lowing seven steps:
(1) Mucosal injection
(2) Partial circumferential incision
(3) Creation of a mucosal flap
(4) Partial submucosal
endoscopic submucosal dissection
Sponsors
Yoshizaki Tetsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject who are 18 years of age and more 2. Subject who understand and voluntarily sign an informed consent form. 3. Subjects who have superficial gastric neoplasm meeting the absolute or expanded indication for E SD according to the following Japanese guidelines for gastric treatment (6 edition): i) clinically diagnosed intramucosal cancer (cT1a) representing well differentiated-type adenocarcin oma of any size, without ulcerative findings ii) cT1a representing well-differentiated-type aden ocarcinoma, less than 30 mm in size, with ulcerati ve findings iii) cT1a representing undifferentiated-type adeno carcinoma, less than 20 mm in size, without ulcera tive findings. 4. Subject who have computed tomography findin gs without any suspicious lesions of lymph node metastasis and distant metastasis. 5. Subject who have histological findings of group 3, 4, and 5 according to group classification of ga stric biopsy. 6. Eastern Cooperative Oncology Group (ECOG) P erformance Status: 0-2 7. Patients scheduled for ESD
Exclusion criteria
Exclusion criteria: 1.Patients receiving antithrombotic therapy 2.Patients with impaired hemostatic or coagulation function (platelet count 1.5) 3.Patients starting dialysis 4.Patients previously enrolled in this clinical study for another lesion 5.Patients with dysfunction of any vital organ meeting any of the following criteria: Liver: AST or ALT >= 3 times the upper limit of normal, or Child-Pugh class B or higher Kidney: eGFR 1.5 mg/dL Heart: NYHA class 3 or higher heart failure 6.Patients with electrolyte abnormalities meeting any of the following criteria: Serum Na 150 mEq/L Serum K 5.5 mEq/L Serum Cl 110 mEq/L 7.Pregnant women, women who may be pregnant, or breastfeeding women 8. Patients deemed unsuitable for sedation (e.g., history of allergy or hypersensitivity to benzodiazepines or dexmedetomidine; prior radiotherapy involving the cervical esophagus; or anticipated difficult airway management due to airway stenosis, anatomical abnormalities, or prior difficult intubation) 9.Any other patients judged inappropriate for this clinical study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostatic time for the initial bleeding episode | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy-related outcomes (hemostatic time for all episodes of bleeding, usage rate of hemostatic f orceps, dissection time, dissection speed, en-bloc complete resection rate, endoscopic curability) 2. Safety-related outcomes (adverse events) | — |
Contacts
Public ContactShinya Hoki
Kobe university hospital
Outcome results
None listed