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)

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) - 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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025447

Enrollment

Registered

2017-01-01

Start date

2016-12-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early stage esophageal cancer after entire circumferential endoscopic submucosal dissection (ESD)

Interventions

Local sterid (triamcinolone acetonide 100mg) injection and shielding with polyglycolic acid sheets and fibrin glue to the mucosal defect immediately after ESD.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Be expected to become entire circumferential mucosal defect after esophageal ESD 2) Over the age of 20 3) Dysphagia score of 0 4) Written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Incidence of stenosis after ESD	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactNoboru Kawata

Shizuoka Cancer Center Division of Endoscopy

n.kawata@scchr.jp055-989-5222

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026