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

Condition(s) studied

Investigational drug(s) / intervention(s)

Submucous Endoscopic Dissection with hydroxyethylamide: The 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): The 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.

Study 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

Primary outcome measure(s)

• Volume of solution — During the procedure
  Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used.

Trial sites (1)

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