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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 : Completed
First Posted : September 22, 2016
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
AdventHealth

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Neoplasms Device: Captivator cassette Other: Standard of Care Not Applicable

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Screening
Official Title: Randomized Trial Comparing Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma
Study Start Date : January 2016
Actual Primary Completion Date : July 2018
Actual Study Completion Date : August 2018

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

    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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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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


Locations
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United States, Florida
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, United States, 32803
Sponsors and Collaborators
AdventHealth
Investigators
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Principal Investigator: Shantel Hebert-Magee, MD Florida Hospital Orlando
More Information
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Publications:

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Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT02911363    
Other Study ID Numbers: 724207
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases