Endosonography-Guided Fine-Needle-Aspiration (EUS-FNA) Versus Key Hole Biopsy (KHB) in Diagnostics of Upper Gastrointestinal Submucosal Tumors - a Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 52
- 试验地点
- 3
- 主要终点
- To compare the yield and success of KHB and EUS-FNA in cytological / histological and immunohistochemical diagnostics of Upper Gastrointestinal Submucosal Tumors.
研究概览
简要总结
Upper Gastrointestinal Submucosal Tumors are tumors arising from subepithelial layers of esophageal, gastric or duodenal wall. They usually have an intact mucosa lining on the inner surface. The prognosis and treatment of these tumors depend on their correct diagnostics and mitotic activity in case of Gastrointestinal Stromal Tumors (GIST). A standard forceps biopsy of mucosa is usually not helpful. Therefore, biopsy techniques capable of reaching deeper layer of Upper GUT are needed. The investigators compare KHB and EUS-FNA in the diagnostics of Upper gastrointestinal Submucosal Tumors.
详细描述
Patients with endoscopically detected submucosal tumors of Upper GUT with diameter ≥ 2cm are enrolled in the trial.
According to randomization, the patients are allocated to either EUS-FNA by 22G needle or KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with subsequent histological/cytological and immunohistochemical evaluation of the specimen. The success of tissue diagnostics was evaluated as well as the possibility to determine the mitotic activity in case of GIST. In case of failure of the initial method, the other method was performed (cross-over design). Patients are hospitalized and kept under observation during 24 hours after the biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Submucosal tumor with endoscopically normal intact mucosa
- •Tumor size: 20mm or more
- •Localization of tumors: esophagus,stomach, duodenum
- •Age: 18 years and older
- •The patient´s consent with a diagnostic procedure .
排除标准
- •Endoscopically nonbuilding tumor
- •Patients younger than 18 years
- •Coagulopathy (INR > 1,5, platelets < 100)
- •Tumor size < 20mm
结局指标
主要结局
To compare the yield and success of KHB and EUS-FNA in cytological / histological and immunohistochemical diagnostics of Upper Gastrointestinal Submucosal Tumors.
时间窗: 5 years
Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are randomized and then are allocated to either EUS-FNA by 22G needle or KHB consisting of forceps biopsy through mucosal incision by a needle knife, both with subsequent histological/cytological and imunohistochemical evaluation of the specimen. The success of tissue diagnostics was evaluated.In case of failure of the initial method, the other method was performed (cross-over design).
次要结局
- Detection of mitotic activity in case of Gastrointestinal Stromal Tumors(5 years)
研究者
Vincent Zoundjiekpon
MD
Vitkovice Hospital