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Trial Title:
Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections
NCT ID:
NCT06077981
Condition:
Esophageal Neoplasms
Endoscopic Mucosal Resection
Hyaluronic Acid
Conditions: Official terms:
Neoplasms
Esophageal Neoplasms
Hyaluronic Acid
Conditions: Keywords:
Esophageal Neoplasms
Endoscopic Mucosal Resection
Hyaluronic Acid
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Primary purpose:
Basic Science
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
Submucous Endoscopic Dissection with hydroxyethylamide
Description:
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.
Arm group label:
Hydroxyethylamide Group
Intervention type:
Procedure
Intervention name:
Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)
Description:
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.
Arm group label:
Hyaluronic acid group (TS-905 Blue Eye)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Instituto do Câncer do Estado de São Paulo
Address:
City:
São Paulo
Zip:
01246-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Fauze Maluf-Filho, PhD
Phone:
+5511991919014
Email:
fauze.maluf@terra.com.br
Start date:
June 19, 2023
Completion date:
March 13, 2025
Lead sponsor:
Agency:
Instituto do Cancer do Estado de São Paulo
Agency class:
Other
Source:
Instituto do Cancer do Estado de São Paulo
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06077981
