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

Esophageal Cancer Clinical Trial

— ESOCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372929
• Other study ID #: 356407
• Status: Completed
• Phase: N/A
• First received: February 16, 2015
• Last updated: February 13, 2017
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: February 2017
• Source: Florida Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• Endoscopic Ultrasound
Esophageal cancer patients will be staged by endoscopic ultrasound. All patients will undergo upper endoscopy prior to endoscopic ultrasound.

Locations

Country	Name	City	State
United States	Florida Hospital Center for Interventional ENdoscopy	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the relationship between tightness of esophageal stricture encountered at endoscopy with cancer staging at EUS.	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.	Intraoperative