Comparison of Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial Comparing Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma

Conditions
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Esophageal Neoplasms

Intervention / Treatment
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* Device: Captivator cassette
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients referred to Florida Hospital Endoscopy Unit for assessment of an esophageal lesion that require EMR Age ≥ 19 years Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capitvator Cassette<br>The EMR specimen will be processed using the Captivator Cassette. | Device: Captivator cassette<br>* The Captivator tissue cassette has an effect on the preservation of tissue histology.<br>|
| Active Comparator: Standard of Care Processing<br>The EMR specimen will be prepared per Standard of Care. | Other: Standard of Care<br>* The specimen will be processed following the College of American Pathology Standards.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review. | 1. Captivator tissue cassette vs. no cassette Captivator tissue cassette with margin curling/artifact vs. Captivator tissue cassette without margin curling/artifact No cassette with margin curling/artifact vs. no cassette without margin curling/artifact Captivator tissue cassette with margin curling/artifact vs. No cassette with margin curling/artifact | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use of the Captivator tissue cassette will be comparable to Standard of Care. | Ease of use of the Captivator tissue cassette will be comparable in terms of handling the histologic specimen and will not add significant time to the intraprocedural or laboratory handling and processing. | 1 year |