Randomized Trial Comparing Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review.
研究概览
简要总结
The main purpose of this study will be to two-fold; firstly to determine whether the use of a Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. The investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of EMR for esophageal lesions.
详细描述
As a result of the advances in endoscopic procedures, the detection of early stage esophageal carcinoma has increased. Endoscopic mucosal resection (EMR) is an innovative technique for removal of high grade intraepithelial neoplasia/dysplasia to prevent the progression of invasive carcinoma which occurs in about a third of patients. EMR involves the endoscopic therapeutic removal of the abnormal esophageal area(s) of tissue by snare or suction, aiming to include as much of the submucosal layer as possible, which is (are) then submitted for histopathological examination for pathological diagnosis and tumor staging. Compared with esophageal biopsy, this methodology reveals more advanced tumor stages in terms of grading and vertical infiltration in 10-20% of patients. Because of the importance of histopathologic diagnosis, the specimen should be pinned on a cork or styrofoam board to prevent curling and maintain the orientation, integrity of the size and shape, and fixed in an appropriate volume of 10% formalin. Unfortunately, specimens are often not pinned as EMR specimens can be difficult and time consuming to pin because of their thickness, hence the specimen integrity (size and shape) and orientation is compromised.
Therefore the main purpose of this study will be to two-fold; firstly to determine whether the use of a Captivator tissue cassette has an effect on the preservation of tissue histology (minimizing artifactual curling) , and secondly to determine whether the use of a intraprocedural cassette is practical. The investigators believe that this will greatly aid in elucidating the best technique for optimizing performance of EMR for esophageal lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients referred to Florida Hospital Endoscopy Unit for assessment of an esophageal lesion that require EMR
- •Age ≥ 19 years
排除标准
- •Age <19 years
- •Unable to safely undergo EMR for any reason
- •Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <80,000/ml)
- •Unable to provide consent for any reason
- •Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential)
研究组 & 干预措施
Capitvator Cassette
The EMR specimen will be processed using the Captivator Cassette.
干预措施: Captivator cassette (Device)
Standard of Care Processing
The EMR specimen will be prepared per Standard of Care.
干预措施: Standard of Care (Other)
结局指标
主要结局
Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review.
时间窗: 1 year
1. Captivator tissue cassette vs. no cassette 1. Captivator tissue cassette with margin curling/artifact vs. Captivator tissue cassette without margin curling/artifact 2. No cassette with margin curling/artifact vs. no cassette without margin curling/artifact 3. Captivator tissue cassette with margin curling/artifact vs. No cassette with margin curling/artifact
次要结局
- Ease of use of the Captivator tissue cassette will be comparable to Standard of Care.(1 year)
