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

RECRUITINGN/ASponsored by Instituto do Cancer do Estado de São Paulo
Actively Recruiting
PhaseN/A
SponsorInstituto do Cancer do Estado de São Paulo
Started2023-06-19
Est. completion2024-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06077981

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

CancerEndoscopic Mucosal ResectionEsophageal NeoplasmsHyaluronic Acid

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