Intralesional Steroid Injection Versus Oral Prednisolone in Prevention of Esophageal Stricture

• Status: Recruiting
• Trial end date: 2021-06-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Treatments: Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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