Gastric Neoplasms
Conditions
Interventions
After gastric ESD, the mucosal defect is closed by using by FLEXLOOP and several clips.
At post-operative day 5-7 and 4-5 weeks, endoscopic examination is performed to confirm the status of mucosal c
Sponsors
Takizawa Kohei
Eligibility
Inclusion criteria
Inclusion criteria: (1)clinically diagnosed early gastric cancer/gastric adenoma, 3cm or less (2)20 years-old or more (3)performance status 0-2 according to the ECOG criteria (4)informed consent obtained
Exclusion criteria
Exclusion criteria: (1)With prior surgery for stomach (2)With psychiatric disorders or psychiatric symptoms (3)With pregnant or lactation woman. (4)With a scheduled surgery for active cancer (including gastric cancer) concurrently. (5)With active bacterial or fungal infections (6)History of myocardial infarction or unstable angina pectoris within 6 months (7)With bleeding or DIC tendency (8)With uncontrollable hypertension (9)With uncontrollable diabetes mellitus (10)With respiratory disease requiring continuous oxygen administration (11)Cases in which doctors in charge regarded as unsuitable to inclusion for the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the rate of complete closure using by FLEXLOOP and several clips | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of FLEXLOOP, Number of clips, The time of closure, The time of procedure time, percentage of en bloc resection, percentage of complete en bloc resection Adverse events (intraoperative perforation, perforation during closure using by FLEXLOOP and clips , massive bleeding during closure using by FLEXLOOP and clips, delayed perforation, delayed bleeding) | — |
Contacts
Public ContactKohei Takizawa
Department of Gastroenterology and Endoscopy, Koyukai Shin-sapporo hospital
Outcome results
None listed