Actively Recruiting
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2025-05-01
30
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two different solutions used during the submucosal cushion formation stage of endoscopic submucosal resections for early esophageal malignant tumors. This randomized clinical trial is conducted at a single center and aims to compare 0.4% hyaluronic acid solution (TS-905 Blue Eye) and hydroxyethylamide solution in treating patients with early esophageal neoplasia. Patients are grouped based on the size of their lesions to ensure balanced comparison. Participants will undergo submucosal endoscopic dissection using either hydroxyethylamide or hyaluronic acid solution. Both procedures involve three stages: delimitation, incision, and dissection. The chosen solution is injected to create a cushion under the lesion, followed by careful cutting around the lesion with specialized equipment. There are two treatment groups, each including 15 patients receiving one of the solutions during their procedure. During the study, researchers will measure the volume of solution used, the duration of the procedure, and the number of additional injections needed. The main goal is to determine which solution better supports complete lesion removal with fewer injections. Participants will be monitored during the procedure, and the study is expected to continue until April 2026, ensuring careful assessment of treatment outcomes and safety throughout the process.
CONDITIONS
Brief Title
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients over 18 years of age
- Superficial esophageal adenocarcinoma or squamous cell carcinoma with indication of endoscopic submucosal dissection after multidisciplinary oncological board discussion
- Signed informed consent form
You will not qualify if you...
- Residual or recurrent esophageal lesions
- Ulcerated esophageal lesions
- Severe cardiovascular, kidney, or liver disease
- History of hypersensitivity to hyaluronic acid
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure visit
Participants undergo submucosal endoscopic dissection with either hydroxyethylamide or hyaluronic acid solution. The procedure includes lesion delimitation, incision, and dissection with submucosal injections.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, Brazil, 01246-000
Actively Recruiting
Research Team
F
Fauze Maluf-Filho, PhD
P
Pierre Pirchner
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here