Gastric epithelial tumor
Conditions
Interventions
None listed
Sponsors
Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients planning to undergo gastric ESD and closure of post-ESD mucosal defect using endoscopic hand suturing (EHS) as an outpatient treatment 2. Preoperative diagnosis of gastric cancer or gastric adenoma (including suspected) of 3 cm or less 3. No endoscopic findings that suggest submucosal invasion 4. Patients aged between 20 and 85 years at the time of consent 5. Patients who give written consent to participate in this study
Exclusion criteria
Exclusion criteria: 1. Patients treated for multiple lesions at the same time (patients with multiple lesions, including those of other organs, can be included if only one lesion is treated during the protocol treatment period). 2. Patients with a history of previous gastrectomy. 3. Severe organ failure (heart, lung, liver, kidney, bone marrow). 4. Patients with lesions located on areas considered extremely difficult to treat (gastric fornix, pylorus) 5. Patients who cannot be managed perioperatively with antithrombotic agents according to the guidelines of the Japanese Gastrointestinal Endoscopy Society 6. A case that the attending physician determines that patient is not suitable for this study 7. A case that patient refuses to participate in this study after enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hospital admissions due to post-operative bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure outcomes (Resection rate, success rate of closure, procedure time, incidence of intra-operative adverse events), incidence of post-operative adverse events, total medical costs incurred during treatment and within 28 days after treatment | — |
Countries
Japan
Contacts
Public ContactTeppei Akimoto
Keio University School of Medicine Division of Research and Development for Minimally Invasive Treatment, Cancer Center
Outcome results
None listed