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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto do Cancer do Estado de São Paulo

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Residual or recurrent esophageal lesions

Ulcerated esophageal lesions

Patients with severe cardiovascular, kidney or liver disease

History of hypersensitivity to hyaluronic acid

Trial design

Treatments tested in this trial

  • Submucous Endoscopic Dissection with hydroxyethylamide
  • Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)

Treatment groups

30 Participants
are divided into 2 treatment groups