Trial Outcomes & Findings for Staging of Superficial EAC Using VLE (NCT NCT03385343)

NCT ID: NCT03385343

Last Updated: 2023-05-09

Results Overview

A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2023-05-09

Participant Flow

Patients undergoing clinical care through our institution's Barrett's esophagus unit.

Participant milestones

Measure	Volumetric Laser Endomicroscopy Patients with Barrett's esophagus and early esophageal adenocarcioma (T1) who were undergoing a clinically indicated endoscopic mucosal resection (EMR) were invited to participate in the study. EMR specimens were imaged (ex-vivo) using volumetric laser endomicroscopy (VLE).
Overall Study STARTED	30
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Staging of Superficial EAC Using VLE

Baseline characteristics by cohort

Measure	Volumetric Laser Endomicroscopy n=30 Participants Patients with Barrett's esophagus and early esophageal adenocarcioma (T1) who were undergoing a clinically indicated endoscopic mucosal resection (EMR) were invited to participate in the study. EMR specimens were imaged (ex-vivo) using volumetric laser endomicroscopy (VLE).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	68.33 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Data was not collected

A validated computer algorithm will be used to quantify the degree of signal attenuation in the T1 EAC endoscopic mucosal resection specimen database. Volumetric Laser Endo-microscopy (VLE) signal attenuation measurements will be correlated to depth of invasion as determined by histology.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 day

Population: Data was not collected

To validate the accuracy of VLE in staging T1 EAC compared to a histologic gold-standard.

Outcome measures

Outcome data not reported

Adverse Events

VLE in Staging T1 EAC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kevin Buller Clinical Research Coordinator

Mayo Clinic

Phone: 507-255-4803

Email: Buller.Kevin@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place