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

NCT06077981 | Recruiting DMC

• 1 other identifier: NP3042/22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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®).

Conditions

Esophageal Neoplasms; Endoscopic Mucosal Resection; Hyaluronic Acid

Keywords

Esophageal Neoplasms; Endoscopic Mucosal Resection; Hyaluronic Acid

Outcome Measures

Primary Outcomes (1)

• Volume of solution

  Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used.

  During the procedure

Secondary Outcomes (2)

• Procedure duration in minutes

  During the procedure

• Number of additional injections

  During the procedure

Study Arms (2)

Hydroxyethylamide Group

ACTIVE COMPARATOR

15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide.

Procedure: Submucous Endoscopic Dissection with hydroxyethylamide

Hyaluronic acid group (TS-905 Blue Eye)

ACTIVE COMPARATOR

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.

Procedure: Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)

Interventions

Submucous Endoscopic Dissection with hydroxyethylamide PROCEDURE

The resection will be performed in three stages using hydroxyethylamide : delimitation, incision and dissection. Initially we will inject the hydroxyethylamide and examine the delimitation of the lesion. With Knife itself, using soft or Forced coagulation current, we will circumvent the limits of the lesion with punctual coagulations 5 mm away from it.

Hydroxyethylamide Group

Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye) PROCEDURE

The resection will be performed in three stages using Hyaluronic acid (TS-905 Blue Eye) : delimitation, incision and dissection. Initially we will inject the Blue-Eyed and examine the delimitation of the lesion. With Knife itself, using soft or Forced coagulation current, we will circumvent the limits of the lesion with punctual coagulations 5 mm away from it.

Hyaluronic acid group (TS-905 Blue Eye)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Fauze Maluf-Filho, PhD

CONTACT

+5511991919014; fauze.maluf@terra.com.br

Pierre Pirchner

CONTACT

+5521986979456; pierrepmm@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomization shall consist of 30 patients, of which: 15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide. 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.

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 11, 2023
• Study Start: June 19, 2023
• Primary Completion: December 30, 2024
• Study Completion: April 13, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

BR (1)