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

Not Applicable

Recruiting

• Conditions: Endoscopic Mucosal Resection; Esophageal Neoplasms; Hyaluronic Acid
• Interventions: Procedure: Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye); Procedure: Submucous Endoscopic Dissection with hydroxyethylamide

• Registration Number: NCT06077981
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

Brief 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®).

Detailed 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 Timeline

• Study Start: 2023-06-19
• Study First Submitted: 2023-09-27
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-11
• Primary Completion: 2024-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Completion: 2026-04-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyaluronic acid group (TS-905 Blue Eye)	Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)	15 will be from the Hyaluronic acid group (TS-905 Blue Eye), where the submucosal endoscopic dissection with submucosal injection of hyaluronic acid (TS-905 Blue Eye) will be performed.
Hydroxyethylamide Group	Submucous Endoscopic Dissection with hydroxyethylamide	15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide.

Primary Outcome Measures

Name	Time	Method
Volume of solution	During the procedure	Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used.

Secondary Outcome Measures

Name	Time	Method
Number of additional injections	During the procedure	Evaluate the number of additional injections need to complete the lesion ressection
Procedure duration in minutes	During the procedure	Evaluate how the procure lasts using each one of the solutions

Trial Locations

Locations (1)

Instituto do Câncer do Estado de São Paulo; 🇧🇷 São Paulo, Brazil