Clinical trial NCT03670134: Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
Official title: The Use of Volumetric Laser Endomicroscopy to Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Barrett Esophagus
Keywords: Laser Endomicroscopy
Intestinal Metaplasia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
First posted: 2018-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Researchers are trying to see if the Nvision® Imaging System (VLE) can accurately determine the risk of recurrent Barrett's esophagus in patients with Barrett's esophagus which have been clear of disease.

Detailed description: Patients with Barrett's Esophagus (BE) undergoing endoscopic therapy through our Barrett's Esophagus Unit will be approached for study enrollment. Patients with no endoscopic evidence of BE will be considered for the study. Surveillance biopsies will be obtained per standard clinical protocol and reviewed to confirm absence of intestinal metaplasia. Patients who have achieved complete eradication of intestinal metaplasia (CRIM) will be enrolled in the study and will undergo the Nvision® Imaging System (VLE). Patients enrolled in the study will undergo clinical follow-up consisting of surveillance endoscopy every 3 months for 1 year. Surveillance endoscopy intervals may be prolonged to every 6 months in the second year, and annually thereafter. At each follow-up visit, endoscopic data will be collected to determine if patients remain in CRIM or show evidence of recurrent disease. Patients will be followed for 1 year (endpoint 1) and 3 years (endpoint 2).

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Eligibility criteria: Inclusion Criteria:

* Patient undergoing an upper endoscopy with prior biopsy confirmed Barrett's Esophagus.
* Ability to provide written, informed consent
* No significant esophagitis (LA grade \<B, C, and D)

Exclusion Criteria:

* Patients for whom use of the NvisionVLE device would be in conflict with the instruction for use.
* Prior esophageal or gastric surgical resection
* Significant esophageal stricture requiring dilatation
* Patients who require anti-coagulation for who biopsy would be contraindicated
* Patients who are known to be pregnant

Primary outcomes:
measure: Determine association between number of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
timeFrame: 1 year
measure: Determine association between distribution of glandular structures measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
timeFrame: 1 year
measure: Determine association between thickness of neosquamous epithelium measured with volumetric laser endomicroscopy and recurrence of Barrett's esophagus following endoscopic therapy
timeFrame: 1 year
Secondary outcomes:
measure: Develop a volumetric laser endomicrosopy feature scoring index to stratify the risk of disease recurrence in patients with Barrett's esophagus following treatment
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Cadman L Leggett, MD
role: PRINCIPAL_INVESTIGATOR
References: