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

Study Overview
=================
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
-----------------
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). 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. 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.

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.

Conditions
-----------------
Esophageal Neoplasms, Endoscopic Mucosal Resection, Hyaluronic Acid

Intervention / Treatment
-----------------
* Procedure: Submucous Endoscopic Dissection with hydroxyethylamide
* Procedure: Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hydroxyethylamide Group<br>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<br>* 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.<br>|
| Active Comparator: Hyaluronic acid group (TS-905 Blue Eye)<br>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)<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of solution | Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used. | During the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure duration in minutes | Evaluate how the procure lasts using each one of the solutions | During the procedure | 
| Number of additional injections | Evaluate the number of additional injections need to complete the lesion ressection | During the procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Neoplasms, Endoscopic Mucosal Resection, Hyaluronic Acid