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 groupsSponsors and collaborators
Source ClinicalTrials.gov