The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm

The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm - The safety and efficacy of a metallic full-coverd stent for preventing stricture after endoscopic submucosal dissection for large esophageal neoplasm

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007688

Enrollment

Registered

2012-08-01

Start date

2012-04-01

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

Superficial esophageal neoplasm which needs semicircumferential (more than three fourths of the circumference of the esophageal lumen) or circumferential ESD

Interventions

We will place a metallic full-covered stent for the patient with a mucosal defect more than three fourths of the circumference by esophageal ESD. The stent placement will be performed under both direc

s condition regularly.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The depth of neoplasm is predicted to be intramucosal or submucosal invasion less than 200 um. 2. The mucosal defect due to ESD is predicted to be three fourths of the circumference. 3. The function of key organs is within normal limits. 4. Those who submit written informed consent.

Exclusion criteria

Exclusion criteria: 1. The case where micro perforation occurs during ESD. 2. The case where the proximal side of the stent may reach pharynx. 3. Those who are suffering from severe diabetes mellitus. 4. Those who received radiation to their esophagus. 5. Those who have psychiatric disease and predicted to have difficulty in participating in this study. In addition, those who are judged to be inappropriate by doctors.

Design outcomes

Primary

Measure	Time frame
The safety (the incidence of severe complications) The efficacy (the number of required endoscopic balloon dilatation within three months after stent removal)	—

Countries

Japan

Outcome results

None listed

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