Status:
UNKNOWN
Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Esophageal Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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. Howeve...
Detailed Description
Endoscopic resection of superficial esophageal neoplasms is widely used as an alternative to esophagectomy, since it is less invasive, besides presenting good clinical results. Compared with esophagec...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of superficial esophageal neoplasm submitted to submucosal endoscopic resection greater than 3/4 of the organ circumference;
- Absence of lymph node or distant metastases, evaluated through echoendoscopy, CT and PET-CT;
- Signed informed consent form
Exclusion
- Presence of invasive esophageal neoplasia
- Hepatical cirrhosis
- Diabetes mellitus with fasting glycemia above 200mg%
- Use of corticosteroids in the 30 days prior to ESD
- INR\> 1.5
- Platelet count less than 50,000
- Active gastrointestinal ulcer
- Severe psychiatric illness
- Glaucoma
- History of allergy or hypersensitivity to corticosteroids or proton pump inhibitor
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 21 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04498260
Start Date
January 21 2019
End Date
June 21 2021
Last Update
August 4 2020
Active Locations (1)
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1
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, Brazil, 01246-000