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®).
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
Residual or recurrent esophageal lesions
Ulcerated esophageal lesions
Patients with severe cardiovascular, kidney or liver disease
History of hypersensitivity to hyaluronic acid
Parallel
Submucous Endoscopic Dissection with hydroxyethylamide
Procedure/SurgeryThe 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.
Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye)
Procedure/SurgeryThe 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.
Volume of solution
Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used.
Procedure duration in minutes
Evaluate how the procure lasts using each one of the solutions
Number of additional injections
Evaluate the number of additional injections need to complete the lesion ressection
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