RecruitingNot ApplicableNCT06077981

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

Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms: a Randomized Clinical Trial.

Sponsor

Instituto do Cancer do Estado de São Paulo

Enrollment

30 participants

Start Date

Jun 19, 2023

Study Type

INTERVENTIONAL

Conditions

Esophageal Neoplasms Hyaluronic Acid Endoscopic Mucosal Resection

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of fluid injected under the lining of the esophagus during endoscopic submucosal dissection (ESD) — a minimally invasive procedure to remove early-stage esophageal cancer. The goal is to see which fluid creates a better cushion for safer, more effective removal. **You may be eligible if...** - You are over 18 years old - You have superficial esophageal cancer (adenocarcinoma or squamous cell carcinoma) and your medical team has recommended ESD - You have signed an informed consent form **You may NOT be eligible if...** - You have residual or recurrent esophageal lesions - You have undergone previous esophageal surgery or radiation to the area - You do not meet other clinical criteria assessed by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESubmucous 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.

PROCEDURESubmucous 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.