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OpenTrials
Completed

NCT Number: NCT02372929

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida Hospital Center for Interventional ENdoscopy

Orlando, Florida, 32804, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Endoscopic Ultrasound

Procedure

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Acronym: ESOCA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 26, 2015
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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