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Recruiting NCT06077981

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

No phase Interventional Esophageal Neoplasms Endoscopic Mucosal Resection Hyaluronic Acid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Submucous Endoscopic Dissection with hydroxyethylamide, Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye).
Who it may be relevant to
Registry conditions: Esophageal Neoplasms, Endoscopic Mucosal Resection, Hyaluronic Acid. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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.

Interventions

  • 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.
  • Procedure 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.

Primary outcome measures

  • Volume of solution [Time frame: During the procedure]
Secondary outcome measures (2)
  • Procedure duration in minutes [Time frame: During the procedure]
  • Number of additional injections [Time frame: During the procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

Brazil · 1 center
  • Instituto do Câncer do Estado de São Paulo — São Paulo

Identifiers

NCT: NCT06077981 · NP3042/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗