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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Cancer
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Florida Hospital Center for Interventional ENdoscopy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients referred for EUS for esophageal cancer staging will be eligible for participation in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AdventHealth
• Investigators: Principal Investigator: Shyam S Varadarajulu, MD, AdventHealth

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: February 16, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimated): February 26, 2015

Study Record Updates

• Last Update Posted (Estimated): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytological Techniques; Biopsy; Cytodiagnosis; Diagnostic Techniques, Surgical; Diagnostic Imaging; Ultrasonography; Biopsy, Fine-Needle; Biopsy, Needle; Image-Guided Biopsy; Ultrasonography, Interventional; Endoscopic Ultrasound-Guided Fine Needle Aspiration
• Other Study ID Numbers: 356407

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A manuscript will be developed upon completion of the study