Status:
RECRUITING
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Conditions:
Esophageal Neoplasms
Endoscopic Mucosal Resection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophage...
Detailed Description
1. Design of the study: This is a randomized clinical trial in a single center. The lesions will be randomized into three blocks based on the diameter of the largest axis (less than 3 cm, between ...
Eligibility Criteria
Inclusion
- Patients over 18 years of age
- Superficial esophageal adenocarcinoma or squamous cell carcinoma with indication of ESD after discussion in a multidisciplinary oncological board
- Signed informed consent form
Exclusion
- Residual or recurrent esophageal lesions
- Ulcerated esophageal lesions
- Patients with severe cardiovascular, kidney or liver disease
- History of hypersensitivity to hyaluronic acid
- Pregnant or lactating women
Key Trial Info
Start Date :
June 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 13 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06077981
Start Date
June 19 2023
End Date
April 13 2026
Last Update
May 1 2025
Active Locations (1)
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1
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000