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.

Not Applicable

• Conditions: Superficial esophageal neoplasms (either squamous cell carcinoma or basaloid carcinoma)

• Registration Number: JPRN-UMIN000015532
• Lead Sponsor: The University of Tokyo Hospital

Brief Summary

published doi:10.1038/ajg.2016.60 Between December 2014 and July 2015, 15 patients were enrolled. Each underwent per-protocol treatment with an ESD defect of over 3/4 the circumference of the esophagus. Four patients were excluded from analysis due to salvage esophagectomy. The remaining 11 patients (2 total circumferential, 9 semi-circumferential) were followed for 12 weeks. Postoperative stricture occurred in 18.2% (2/11), with a median of 0 sessions of EBD required. Postoperative stricture was successfully prevented in one case of total circumferential resection. Of the semi-circumferential cases, postoperative stricture occurred in 11.1% (1/9), with a median of 0 EBD sessions.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-26
• Study Completion: 2015-11-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified