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

NCT ID: NCT02372929

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Endoscopic Ultrasound Staging

Prospective study of esophageal cancer patients referred for endoscopic ultrasound

Endoscopic Ultrasound

Intervention Type PROCEDURE

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

Interventions

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Endoscopic Ultrasound

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shyam S Varadarajulu, MD

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

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Florida Hospital Center for Interventional ENdoscopy

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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356407

Identifier Type: -

Identifier Source: org_study_id