Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections

• 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 3 - 5 cm and greater than 5 cm).

• Selection of patients:

The population studied will be patients with early esophageal neoplasia diagnosed and/or referred for submucosal endoscopic dissection at the São Paulo Cancer Institute (ICESP), University of São Paulo.

• Evaluation of effectiveness and definitions:

Effectiveness will be measured from the degree of usefulness. The degree of utility will be determined from two variables: obtaining or not a complete block resection and additional number of submucosal injections performed during endoscopic dissection. The solution that results in a complete block resection with a number of additional injections of 0 (excellent utility degree) or 1 (good utility degree) will be considered effective.

Inclusion criteria

• 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 criteria

• 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