Exploratory clinical study concerning the efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms.

Exploratory clinical study concerning the efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms. - The efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000015532

Enrollment

Registered

2014-10-26

Start date

2014-10-29

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 neoplasms (either squamous cell carcinoma or basaloid carcinoma)

Interventions

Application of &quot

steroid injection&quot

and &quot

shielding method with polyglycolic acid sheets and fibrin glue&quot

after esophageal ESD.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Superficial esophageal neoplasm (either squamous cell carcinoma or basaloid carcinoma) is pathologically diagnosed by endoscopic biopsy. 2) The neoplasm is located in the thoracic esophagus. 3) Lymph node metastasis is ruled out through CT examination. 4) The neoplasm meets either of the 2 following criteria: 1. a single neoplasm covering over half the circumference of the esophagus 2. multiple neoplasms that will require mucosal resection of over 3/4 the circumference of the esophagus 5) There will be only a single ESD defect. 6) The patient must be above 20 years of age. 7) The performance status of the patient must be 0-2. 8) The patient's dysphagia score must be 0. 9) Blood examination results must meet the following criteria: 1.Hb>=8.0g/dL 2.Plt>=100,000/mm3 3.AST,ALT<=150 4.Cre<=2.0mg/dL 10) Followup of the patient for 12 weeks after ESD must be possible. 11) Informed consent after sufficient explanation must be obtained.

Exclusion criteria

Exclusion criteria: 1) The patient has received endoscopic treatment of the upper GI tract within 30 days of entry. 2) The patient is to receive endoscopic treatment of either the stomach or duodenum in the same session. 3) The patient has plans of receiving endoscopic treatment of the upper GI tract within 12 weeks. 4) The patient has allergy to either Lugol staining, polyglycolic acid, steroids, PPIs. 5) Possibility of pregnancy 6) Neuropsychiatric symptoms which may impair comprehension of the study. 7) A history of either angina or cardiac infarction within 3 months 8) Uncontrolled hypertension 9) Others

Design outcomes

Primary

Measure	Time frame
Number of endoscopic balloon dilation sessions required (within 12 weeks after ESD)	—

Countries

Japan

Contacts

Public ContactYoshiki Sakaguchi

The University of Tokyo Hospital The Department of Gastroenterology

sakaguchi-tky@umin.ac.jp03-3815-5411

Outcome results

None listed

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

Exploratory clinical study concerning the efficacy of &quot;steroid injection&quot; and &quot;shielding method with polyglycolic acid sheets and fibrin glue&quot; for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms.