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

Esophageal Neoplasms Clinical Trial

Official title:
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms: a Randomized Clinical Trial.

Clinical Trial Summary

This is a randomized, single-center clinical trial that will compare the efficacy of two substances used in the submucosal cushion formation stage of endoscopic submucosal resections of early esophageal malignant neoplasms. Such substances are hyaluronic acid in the form of TS-905 Blue Eyeₒ and hydroxyethylamide (Voluven®).

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06077981
Study type Interventional
Source Instituto do Cancer do Estado de São Paulo
Contact Fauze Maluf-Filho, PhD
Phone +5511991919014
Email fauze.maluf@terra.com.br
Status Recruiting
Phase N/A
Start date June 19, 2023
Completion date March 13, 2025
View Details
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