Early Stage Gastric Cancer/Gastric Tumor
Conditions
Interventions
Suture/close the ulcer bottom after gastric ESD using the MANTIS Closure Device, EZ clip.
Sponsors
Nagasaki University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Early stage gastric cancer diagnosed by preoperative endoscopy as an absolute indication for endoscopic resection or an extended indication according to the guidelines for gastric cancer treatment. (2) Early-stage gastric cancer with no clinical metastasis diagnosed by CT, echography, or other imaging methods. (3i) Male and female patients aged 20 years or older at the time of consent, who have given their written consent.
Exclusion criteria
Exclusion criteria: (1) Patients have active multiple cancers. However, intraepithelial or intramucosal carcinoma that can be cured by endoscopic treatment is eligible. (2) The patient has the following serious complications: (i) Serious hepatic disorder Serious hepatic disorder Serious cardiac disease (myocardial infarction, angina pectoris, congestive heart failure, etc.) Serious renal disorder (3) Serious infectious disease. (4) Women who are pregnant or may become pregnant. Women who are lactating. (5) Patients with serious bleeding or in shock. (6) Patients with bleeding tendency. (7) Patients who are currently participating in another clinical trial or for whom at least 3 months have not elapsed since the completion of the trial. (8) Other patients whom the investigators/associate investigators deem inappropriate as subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| posterior hemorrhage | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Intraoperative bleeding control (2) Lump-sum complete resection rate, lump-sum curative resection rate, lump-sum resection rate (3) MANTIS Closure Device residual duration and residual rate. (4) Incidence of thromboembolism in the perioperative period. (5) Resection time | — |
Countries
Japan
Contacts
Public ContactKohei Sato
Nagasaki University Hospital gastroenterology
Outcome results
None listed