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The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy

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: NCT03859557
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Collaborator:
Foundation for Surgical Innovation and Education
Information provided by (Responsible Party):
Steven DeMeester, The Oregon Clinic

Brief Summary:

Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms or undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation.

At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.


Condition or disease
GERD Barrett Esophagus Low Grade Esophageal Glandular Dysplasia Esophageal Diseases

Detailed Description:

Patients scheduled to undergo routine upper endoscopy for foregut or esophageal symptoms will be enrolled. Patients undergoing surveillance for Barrett's esophagus with no dysplasia or low-grade dysplasia are candidates for participation, but patients with known high-grade dysplasia or adenocarcinoma or with a history of prior endoscopic resection or ablation for these conditions are not candidates for participation. Informed consent will be obtained from every patient prior to enrollment.

Patients will be randomized prior to starting the procedure. Each patient will receive a randomization code at the time of randomization. It is important that the randomization code be included in the Case Report Form submitted with each patient, and will represent the unique deidentified code for each patient's data for inclusion in the study database.

At endoscopy, all patients will be initially assessed for the presence of an endoscopic suspicious lesion using white light and if appropriate narrow band imaging or similar enhanced imaging techniques. All suspicious lesions undergo targeted biopsy first, and then either 4-Quadrant Random Forceps Biopsy or WATS biopsies of the GEJ and if present the columnar-lined esophagus based on the assigned randomization away from the area of targeted biopsies. A biopsy will be obtained from the antrum in each patient to assess for H. pylori infection and the presence of intestinal metaplasia.

Targeted forceps biopsies of any endoscopic suspicious area will be placed in a separate pathology bottle from those obtained from 4-Quadrant Random Forceps Biopsy and analyzed separately as well.

All the components needed to perform WATS biopsies are included in a kit with complete written instructions.

WATS specimens will be analyzed by CDx Diagnostics. Investigator will ship the WATS specimens to CDx Diagnostics in accordance with CDx's instructions. Forceps biopsies will be analyzed by institution's pathology department and the pathology department of each additional site participating in the Study per standard protocol.

The Investigator will determine appropriate follow-up of patients with and without IM or dysplasia detected by WATS or FB per standard individual and / or institution protocol.

Investigator and all investigators at the additional sites will supply the study coordinator with de-identified data for each specimen, such de-identified data including patient demographics, endoscopic findings, and results of the FB of GEJ, antrum plus / minus esophagus. Study Data will be maintained on a secure database by the study coordinator during the Term and for six years thereafter.

Biopsies with intestinal metaplasia or dysplasia may be reviewed by a central pathologist to confirm the original pathologic interpretation when there is a discrepancy between WATS and FB that is greater than 10%.

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Study Type : Observational
Actual Enrollment : 1032 participants
Official Title: The Evaluation of Patients With Esophageal and Foregut Disorders With WATS (Wide Area Transepithelial Sample With 3-Dimensional Computer-Assisted Analysis) vs. 4-Quadrant Forceps Biopsy
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort
4-Quadrant Random Forceps Biopsy
Random sampling within a quadrant of esophageal tissue using forceps.
WATS biopsies
Wide area transepithelial sampling with computer aided pathologic interpretation of tissue.



Primary Outcome Measures :
  1. Yield of WATS biopsies compared to Forceps biopsies [ Time Frame: 12 months ]
    Intestinal metaplasia is a premalignant change in the normal epithelium lining the esophagus and gastroesophageal junction. It is evaluated on tissue samples from these areas by a pathologist under a microscope, who then determines if intestinal metaplasia is present or not. All specimens retrieved by upper endoscopy, whether by standard biopsy or by WATS, will be examined by a pathologist. The pathology reports will be reviewed and the frequency that intestinal metaplasia is found by standard biopsy vs WATS will be statistically compared.



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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Eligible patients are those who undergo routine upper endoscopy while under sedation to evaluate foregut or esophageal symptoms.
Criteria

Inclusion Criteria:

  • Both males and females at least 18 years of age undergoing routine upper endoscopy to evaluate symptoms of esophageal or foregut disorders (reflux disease, BE, esophageal strictures, swallowing disorders, dyspepsia, hiatal hernias, motility issues, gastric issues).
  • Institutional Review Board (IRB)-approved consent must be signed by patients prior to participating in this study.

Exclusion Criteria:

  • Patients who do not undergo either FB or WATS biopsy
  • Patients with inadequate WATS or FB specimens
  • Known history of high-grade dysplasia or adenocarcinoma
  • Prior history of endoscopic resection or ablation for Barrett's with high-grade dysplasia or adenocarcinoma

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): NCT03859557


Locations
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United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
CDx Diagnostics
Foundation for Surgical Innovation and Education
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Responsible Party: Steven DeMeester, MD, President and Executive Director The Foundation for Research and Education in Esophageal and Foregut Disease, The Oregon Clinic
ClinicalTrials.gov Identifier: NCT03859557    
Other Study ID Numbers: CDx 810b
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Barrett Esophagus
Esophageal Diseases
Precancerous Conditions
Neoplasms
Gastrointestinal Diseases
Digestive System Diseases