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

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AdventHealth

Status

Completed

Conditions

Esophageal Neoplasms

Treatments

Device: Captivator cassette
Other: Standard of Care

Study type

Interventional

Funder types

Other

Identifiers

NCT02911363
724207

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Capitvator Cassette
Active Comparator group
Description:
The EMR specimen will be processed using the Captivator Cassette.
Treatment:
Device: Captivator cassette
Standard of Care Processing
Active Comparator group
Description:
The EMR specimen will be prepared per Standard of Care.
Treatment:
Other: Standard of Care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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