Relationship Between Endoscopic Ultrasound Staging and Degree of Stricture in Esophageal Cancer



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/15/2017
Start Date:April 2012
End Date:April 2014

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The primary objective of this study is to document all cases of EUS in patients with
esophageal cancer and determine if the inability to advance the gastroscope beyond the tumor
correlates with locally advanced disease stage at Endoscopic Ultrasound.

This will be an observational prospective study. The investigators will aim to enroll 100
male and female adult patients (aged 19 years and over) of all ethnicities/races, who have
been referred to Florida Hospital for Endoscopic Ultrasound staging of esophageal cancer.
All vulnerable populations will be excluded.

The investigators will be using a standardized data collection form to record presenting
symptoms, endoscopy findings, Endoscopic Ultrasound features and final esophageal cancer
staging. This is an observational study in which standard of care is being practiced and
also as the patients are not placed at additional risk from participating in this study.
However, as the investigators are collecting data prospectively, all participants will sign
consent. An attempt will be made to see if there is a correlation between stricture
tightness encountered at endoscopy (EGD) with advanced disease stage diagnosed at Endoscopic
Ultrasound.

Inclusion Criteria:

1.All patients aged > 18 yrs, who can provide informed consent and referred to Florida
Hospitals Endoscopy Unit for EUS staging of esophageal cancer.

Exclusion Criteria:

1. Age < 18 yrs

2. Inability to provide informed consent.

3. Unable to safely undergo endoscopy for any reason

4. Coagulopathy (prolongation of Prothrombin time > 18 secs, thrombocytopenia < 80,000
platelets/ml)

5. Limited mental capacity or language skills to the extent simple instructions cannot
be followed or information regarding adverse events and follow-up phone visits cannot
be provided

6. Non-English speaking without a translator.
We found this trial at
1
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Orlando, FL
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