A multi-centered study of feasibility in endoscopic closure using novel simple flexible device for mucosal defect after gastric endoscopic submucosal dissection

JRCT ID: jRCT1072220065

Registered date:02/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric Neoplasms
• Date of first enrollment: 02/11/2022
• Target sample size: 35
• Study type: Interventional

Intervention(s)

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 closure.

Outcome(s)

• Primary Outcome: The primary endpoint is the rate of complete closure using by FLEXLOOP and several clips

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable

Include 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

Exclude 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

Related Information

• Primary Sponsor: Takizawa Kohei
• Source(s) of Monetary Support: J-CASE Research Grant