Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms: a Randomized Clinical Trial.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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®).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Brazil
Instituto do Câncer do Estado de São Paulo
RECRUITING
São Paulo
Contact Information
Primary
Fauze Maluf-Filho, PhD
fauze.maluf@terra.com.br
+5511991919014
Backup
Pierre Pirchner
pierrepmm@hotmail.com
+5521986979456
Time Frame
Start Date: 2023-06-19
Estimated Completion Date: 2026-04-13
Participants
Target number of participants: 30
Treatments
Active_comparator: Hydroxyethylamide Group
15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide.
Active_comparator: Hyaluronic acid group (TS-905 Blue Eye)
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.
Related Therapeutic Areas
Sponsors
Leads: Instituto do Cancer do Estado de São Paulo