Comparison of Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma
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|ClinicalTrials.gov Identifier: NCT02911363|
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : May 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Neoplasms||Device: Captivator cassette Other: Standard of Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Randomized Trial Comparing Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||August 2018|
Active Comparator: Capitvator Cassette
The EMR specimen will be processed using the Captivator Cassette.
Device: Captivator cassette
The Captivator tissue cassette has an effect on the preservation of tissue histology.
Active Comparator: Standard of Care Processing
The EMR specimen will be prepared per Standard of Care.
Other: Standard of Care
The specimen will be processed following the College of American Pathology Standards.
- Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review. [ Time Frame: 1 year ]
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
- Ease of use of the Captivator tissue cassette will be comparable to Standard of Care. [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02911363
|Contact: Shantel Hebert-Magee, MD||407.303.2750||Snatel.Hebert-Magee@flhosp.org|
|Contact: Robin E Barron-Nelson, RN, MSN||407.303.5503||Robin.Barron@hotmail.com|
|United States, Florida|
|Center for Interventional Endoscopy - Florida Hospital||Recruiting|
|Orlando, Florida, United States, 32803|
|Contact: Shantel Hebert-Magee, MD 407-303-2750 Shantel.Hebert-Magee.MD@flhosp.org|
|Contact: Robin E Barron-Nelson, RN. MSN 407.303.5503 Robin.Barron@flhosp.org|
|Principal Investigator:||Shantel Hebert-Magee, MD||Florida Hospital Orlando|