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A validation study of local steroid injection therapy with endoscopic tissue shielding method using polyglycolic sheet and fibrin glue for the prevention of stricture after entire circumferential esophageal endoscopic submucosal dissection (PF-E)

Basic Information

Recruitment status	Complete: follow-up continuing
Health condition(s) or Problem(s) studied	Early stage esophageal cancer after entire circumferential endoscopic submucosal dissection (ESD)
Date of first enrollment	2016/12/07
Target sample size	11
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Local sterid (triamcinolone acetonide 100mg) injection and shielding with polyglycolic acid sheets and fibrin glue to the mucosal defect immediately after ESD.

Outcome(s)

Primary Outcome	Incidence of stenosis after ESD
Secondary Outcome	The number and period of endoscopic dilation, the coverage rate, the time of cover the mucosal defect, PGA sheets residual rate one week later, the number of endoscopic dilation of 12 weeks after ESD, stricture-free survival of 12 weeks after ESD, adverse events

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	Not applicable
Gender	Male and Female
Include criteria
Exclude criteria	1) Active infection requiring systemic therapy 2) Pregnancy, possible pregnancy, within 28 days after delivery or breastfeeding 3) Hypersensitivity for triamcinolone acetone 4) Severe psychiatric disease