Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372929
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
AdventHealth

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.

Condition or disease Intervention/treatment
Esophageal Cancer 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Relationship Between Endoscopic Ultrasound Staging and Degree of Stricture in Esophageal Cancer
Study Start Date : April 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372929


Locations
Layout table for location information
United States, Florida
Florida Hospital Center for Interventional ENdoscopy
Orlando, Florida, United States, 32804
Sponsors and Collaborators
AdventHealth
Investigators
Layout table for investigator information
Principal Investigator: Shyam S Varadarajulu, MD AdventHealth
Layout table for additonal information
Responsible Party: AdventHealth
ClinicalTrials.gov Identifier: NCT02372929    
Other Study ID Numbers: 356407
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A manuscript will be developed upon completion of the study
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases