Comparison of Captivator Tissue Cassettes vs. no Cassettes for Endoscopic Mucosal Resection in Esophageal Carcinoma
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 2/13/2019 |
| Start Date: | January 2016 |
| End Date: | August 2018 |
Randomized Trial Comparing 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.
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.
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.
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.
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)
We found this trial at
1
site
601 East Rollins Street
Orlando, Florida 32803
Orlando, Florida 32803
Phone: 407-303-2750
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