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Completed

NCT Number: NCT02911363

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Interventional Endoscopy - Florida Hospital

Orlando, Florida, 32803, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Captivator cassette

Device

The Captivator tissue cassette has an effect on the preservation of tissue histology.

Standard of care

Other

The specimen will be processed following the College of American Pathology Standards.

Primary outcomes

  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

    • 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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 22, 2016
Registry last updated
Feb 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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