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

NCT02372929 | Completed

• 1 other identifier: 356407
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Endoscopic Ultrasound Staging

Prospective study of esophageal cancer patients referred for endoscopic ultrasound

Procedure: Endoscopic Ultrasound

Interventions

Endoscopic Ultrasound PROCEDURE

Esophageal cancer patients will be staged by endoscopic ultrasound. All patients will undergo upper endoscopy prior to endoscopic ultrasound.

Endoscopic Ultrasound Staging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients aged \> 18 yrs, who can provide informed consent and referred to Florida Hospitals Endoscopy Unit for EUS staging of esophageal cancer.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital Center for Interventional ENdoscopy

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Shyam S Varadarajulu, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: February 26, 2015
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 12, 2025

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)