Relationship Between Endoscopic Ultrasound Staging and Degree of Stricture in Esophageal Cancer (ESOCA)
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|ClinicalTrials.gov Identifier: NCT02372929|
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 14, 2017
|Condition or disease||Intervention/treatment|
|Esophageal Cancer||Procedure: 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.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Relationship Between Endoscopic Ultrasound Staging and Degree of Stricture in Esophageal Cancer|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Endoscopic Ultrasound Staging
Prospective study of esophageal cancer patients referred for endoscopic ultrasound
Procedure: Endoscopic Ultrasound
Esophageal cancer patients will be staged by endoscopic ultrasound. All patients will undergo upper endoscopy prior to endoscopic ultrasound.
- Evaluate the relationship between tightness of esophageal stricture encountered at endoscopy with cancer staging at EUS. [ Time Frame: Intraoperative ]The investigators hypothesize that if the stricture (cancer) in the esophagus is high-grade it will preclude passage of the endoscope and subjects on endoscopic ultrasound are likely to have advance-stage disease. An attempt will be made to correlate the relationship between stricture tightness and disease stage of esophageal cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372929
|United States, Florida|
|Florida Hospital Center for Interventional ENdoscopy|
|Orlando, Florida, United States, 32804|
|Principal Investigator:||Shyam S Varadarajulu, MD||AdventHealth|