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

Not Applicable

Completed

• Conditions: Esophageal Neoplasms
• Interventions: Device: Captivator cassette; Other: Standard of Care

• Registration Number: NCT02911363
• Lead Sponsor: AdventHealth

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-12
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-22
• Primary Completion: 2018-07
• Study Completion: 2018-08
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capitvator Cassette	Captivator cassette	The EMR specimen will be processed using the Captivator Cassette.
Standard of Care Processing	Standard of Care	The EMR specimen will be prepared per Standard of Care.

Primary Outcome Measures

Name	Time	Method
Histological quality of the EMR specimen obtained during the procedure will be analyzed and compared to cassette vs. no cassette for pathology review.	1 year	1. Captivator tissue cassette vs. no cassette; 1. Captivator tissue cassette with margin curling/artifact vs. Captivator tissue cassette without margin curling/artifact; 2. No cassette with margin curling/artifact vs. no cassette without margin curling/artifact; 3. Captivator tissue cassette with margin curling/artifact vs. No cassette with margin curling/artifact

Secondary Outcome Measures

Name	Time	Method
Ease of use of the Captivator tissue cassette will be comparable to Standard of Care.	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.

Trial Locations

Locations (1)

Center for Interventional Endoscopy - Florida Hospital; 🇺🇸 Orlando, Florida, United States