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 Details — Status: Recruiting

Administrative data

• NCT number: NCT06077981
• Other study ID #: NP3042/22
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2023
• Est. completion date: March 13, 2025

Study information

• Verified date: October 2023
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: Fauze Maluf-Filho, PhD
• Phone: +5511991919014
• Email: fauze.maluf[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

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®).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 13, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Mucosal Resection
• Esophageal Neoplasms
• Hyaluronic Acid
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto do Câncer do Estado de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of solution	Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used.	During the procedure
Secondary	Procedure duration in minutes	Evaluate how the procure lasts using each one of the solutions	During the procedure
Secondary	Number of additional injections	Evaluate the number of additional injections need to complete the lesion ressection	During the procedure