Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture

NCT04498260 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-08-04

No results posted yet for this study

Summary

Endoscopic resection of superficial esophageal neoplasms is already a reality and presents important advantages when compared to esophagectomy as fewer complications and better quality of life. However, extensive resections can lead to difficult-to-manage stenoses. There are several therapies available in order to prevent this stenosis but, to date, there is no definition of the gold standard.

The objective of this study was to compare the use of intralesional steroid injection versus oral prednisolone after endoscopic submucosal dissection and to evaluate the stenosis rate, number of dilations to resolve the stenosis and complications.

Conditions

  • Esophageal Stenosis

Interventions

DRUG

Local steroid - triamcinolone acetonide

(triamcinolone acetonide)

DRUG

Oral steroid - predonisolone

(predonisolone)

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-21
Primary Completion
2021-03-21
Completion
2021-06-21

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04498260 on ClinicalTrials.gov