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

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02911363
• Other study ID #: 724207
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: February 2019
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

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

Other:
• Standard of Care
The specimen will be processed following the College of American Pathology Standards.

Locations

Country	Name	City	State
United States	Center for Interventional Endoscopy - Florida Hospital	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Blot WJ, McLaughlin JK. The changing epidemiology of esophageal cancer. Semin Oncol. 1999 Oct;26(5 Suppl 15):2-8. Review. — View Citation

Devesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53. — View Citation

Lagergren J, Bergström R, Lindgren A, Nyrén O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med. 1999 Mar 18;340(11):825-31. — View Citation

Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review.	1. 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	1 year
Secondary	Ease of use of the Captivator tissue cassette will be comparable to Standard of Care.	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.	1 year