Skip to main content
Clinical Trials/NCT02372929
NCT02372929
Completed
Not Applicable

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

AdventHealth1 site in 1 country100 target enrollmentApril 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Cancer
Sponsor
AdventHealth
Enrollment
100
Locations
1
Primary Endpoint
Evaluate the relationship between tightness of esophageal stricture encountered at endoscopy with cancer staging at EUS.
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2012
End Date
April 1, 2014
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Age \< 18 yrs
  • Inability to provide informed consent.
  • Unable to safely undergo endoscopy for any reason
  • Coagulopathy (prolongation of Prothrombin time \> 18 secs, thrombocytopenia \< 80,000 platelets/ml)
  • 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
  • Non-English speaking without a translator.

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials