Endoscopic Mucosal Resection, Esophageal Neoplasms, Hyaluronic Acid
Conditions
Keywords
Esophageal Neoplasms, Endoscopic Mucosal Resection, Hyaluronic Acid
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.
Interventions
PROCEDURESubmucous 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.
PROCEDURESubmucous 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.
Sponsors
Instituto do Cancer do Estado de São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume of solution | During the procedure | Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure duration in minutes | During the procedure | Evaluate how the procure lasts using each one of the solutions |
| Number of additional injections | During the procedure | Evaluate the number of additional injections need to complete the lesion ressection |
Countries
Brazil
Contacts
CONTACTFauze Maluf-Filho, PhD
CONTACTPierre Pirchner
Outcome results
None listed