Comparing two solutions for endoscopic removal of early esophageal cancer
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms: a Randomized Clinical Trial.
This study is testing two different solutions to see which one works better for safely removing early esophageal cancer in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06077981 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, single-center study that aims to compare the efficacy of 0.4% hyaluronic acid solution and hydroxyethylamide solution during submucosal endoscopic resections of early esophageal neoplasms. Patients with superficial esophageal adenocarcinoma or squamous cell carcinoma will be enrolled and randomized based on the size of their lesions. The effectiveness of each solution will be evaluated based on the success of complete block resections and the number of additional injections required during the procedure. The study is conducted at the São Paulo Cancer Institute, focusing on improving outcomes for patients undergoing this type of endoscopic dissection.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with early-stage superficial esophageal adenocarcinoma or squamous cell carcinoma indicated for endoscopic submucosal dissection.
Not a fit: Patients with residual or recurrent esophageal lesions, ulcerated lesions, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of endoscopic procedures for early esophageal cancer, potentially leading to better patient outcomes.
How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in improving endoscopic techniques for cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
São Paulo, São Paulo
- Instituto do Câncer do Estado de São Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Fauze Maluf-Filho, PhD
- Email: fauze.maluf@terra.com.br
- Phone: +5511991919014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.