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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-08-31

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.

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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.

Conditions

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Esophageal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Capitvator Cassette

The EMR specimen will be processed using the Captivator Cassette.

Group Type ACTIVE_COMPARATOR

Captivator cassette

Intervention Type DEVICE

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

Standard of Care Processing

The EMR specimen will be prepared per Standard of Care.

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

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

Interventions

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Captivator cassette

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

Intervention Type DEVICE

Standard of Care

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

Intervention Type OTHER

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)

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No