Randomized Trial Comparing 0.4% Hyaluronic Acid and Hydroxyethylamide Solutions for Early Esophageal Cancer Submucosal Endoscopic Resection

What this Trial Is About

Researchers are evaluating the effectiveness of two substances used during the submucosal cushion formation stage of endoscopic submucosal resections for early esophageal malignant tumors. This randomized, single-center clinical trial compares a 0.4% hyaluronic acid solution called TS-905 Blue Eye against a hydroxyethylamide solution Voluven. The study aims to determine which solution better supports complete block resection with fewer additional injections during the procedure. Participants will be randomly assigned to one of two groups one group receiving submucosal endoscopic dissection with hydroxyethylamide injections, and the other with hyaluronic acid TS-905 Blue Eye injections. The resection procedure includes three stagesdelimitation, incision, and dissectionwhere the assigned solution is injected to help separate the lesion from underlying tissue. Patients are grouped based on lesion size for balanced comparison. During the study, researchers will measure the volume of solution used, the number of additional injections needed, and the duration of the procedure. These measurements will help assess the utility of each solution. The trial involves careful monitoring of the procedure and outcomes to evaluate effectiveness. Participants involvement includes undergoing the endoscopic procedure as assigned and consenting to study participation and follow-up assessments.

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