Comparison of 0.4% Hyaluronic Acid Solution Versus Hydroxyethylamide Solution in Submucosal Endoscopic Resections of Superficial Malignant Esophageal Neoplasms: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Volume of solution
研究概览
简要总结
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®).
详细描述
- Design of the study:
This is a randomized clinical trial in a single center. The lesions will be randomized into three blocks based on the diameter of the largest axis (less than 3 cm, between 3 - 5 cm and greater than 5 cm). 2. Selection of patients:
The population studied will be patients with early esophageal neoplasia diagnosed and/or referred for submucosal endoscopic dissection at the São Paulo Cancer Institute (ICESP), University of São Paulo. 3. Evaluation of effectiveness and definitions:
Effectiveness will be measured from the degree of usefulness. The degree of utility will be determined from two variables: obtaining or not a complete block resection and additional number of submucosal injections performed during endoscopic dissection. The solution that results in a complete block resection with a number of additional injections of 0 (excellent utility degree) or 1 (good utility degree) will be considered effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Hydroxyethylamide Group
15 will be from the hydroxyethylamide Group, where the submucosal endoscopic dissection will be performed with submucosal injection of hydroxyethylamide.
干预措施: Submucous Endoscopic Dissection with hydroxyethylamide (Procedure)
Hyaluronic acid group (TS-905 Blue Eye)
15 will be from the Hyaluronic acid group (TS-905 Blue Eye), where the submucosal endoscopic dissection with submucosal injection of hyaluronic acid (TS-905 Blue Eye) will be performed.
干预措施: Submucous Endoscopic Dissection with Hyaluronic acid (TS-905 Blue Eye) (Procedure)
结局指标
主要结局
Volume of solution
时间窗: During the procedure
Compare the volume of TS-905 Blue Eye versus the solution of hydroxyethylamide used.
次要结局
- Procedure duration in minutes(During the procedure)
- Number of additional injections(During the procedure)
研究者
Fauze Maluf Filho
Principal Investigator
Instituto do Cancer do Estado de São Paulo