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

Completed

• Conditions: Esophageal Cancer
• Interventions: Procedure: Endoscopic Ultrasound

• Registration Number: NCT02372929
• Lead Sponsor: AdventHealth

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2012-04
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Study First Submitted: 2015-02-16
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-26
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-13
• Last Update Posted: 2017-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic Ultrasound Staging	Endoscopic Ultrasound	Prospective study of esophageal cancer patients referred for endoscopic ultrasound

Primary Outcome Measures

Name	Time	Method
Evaluate the relationship between tightness of esophageal stricture encountered at endoscopy with cancer staging at EUS.	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.

Trial Locations

Locations (1)

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