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CompletedNCT02372929ESOCAUpdated Nov 12, 2025

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

An observational study in Esophageal Cancer, sponsored by AdventHealth. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-12.

Sponsored by AdventHealth · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Esophageal Cancer
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In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's enrollment of 100 is below the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

AdventHealth is the lead sponsor of 107 studies on the registry; 25 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Endoscopic Ultrasound Staging

    Prospective study of esophageal cancer patients referred for endoscopic ultrasound

    Procedure: Endoscopic Ultrasound

Interventions

  • ProcedureEndoscopic Ultrasound

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

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What researchers measure

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.

    Time frame: Intraoperative

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Study locations

1 site
  • Florida Hospital Center for Interventional ENdoscopy
    Orlando, Florida 32804, United States
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References and documents

Individual participant data

Plan to share: Yes — A manuscript will be developed upon completion of the study

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02372929
Lead sponsor
AdventHealth
Responsible party
Sponsor
First posted
Feb 26, 2015
Start date
Apr 2012
Primary completion
Apr 2014
Completion
Apr 2014
Last update
Nov 12, 2025

Study contacts

Shyam S Varadarajulu, MD
principal investigator · AdventHealth

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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