Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
30 patients around the world
Available in Brazil
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 3 -
5 cm and greater than 5 cm).
2. 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.
3. 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.
Instituto do Cancer do Estado de São Paulo
1Research sites
30Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
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
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
Sites
Fundação Faculdade de Medicina - Instituto do Cancer do Estado de São Paulo
Recruiting
Av. Dr. Arnaldo, 455 - Cerqueira César, Pacaembu - SP, 01246-903