CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

Not Applicable

Completed

Conditions: Adenocarcinoma
Barrett's Esophagus
Barrett Esophagus
Barrett Syndrome
Barrett's Syndrome

Interventions: Device: pCLE guided evaluation
Device: Standard endoscopic evaluation

Brief Summary: This study focuses on demonstrating the value of probe-based Confocal Laser Endomicroscopy (pCLE) in guiding endoscopic therapeutic procedures in Barrett's Esophagus (BE).

It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

Detailed Description: It is a randomized controlled outcomes study including patients already treated for Barrett's Esophagus lesion(s) and undergoing high definition white light endoscopy follow up procedure, with or without pCLE guided evaluation (2 arms will be considered in this study). The procedures will be carried out per standards of practice with appropriately trained physicians.

Recruitment & Eligibility

Inclusion Criteria

Patients with BE with Intestinal Metaplasia, Low Grade-IntraEpithelial Neoplasia/High Grade-IntraEpithelial Neoplasia as the original indication for ablative treatment.
Undergoing any type of endoscopic BE ablation treatment
<2cm of circumferential BE and <5 total islands of BE on prior to last ablation.
Age > 18 years
Ability to provide written, informed consent

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
pCLE-guided evaluation	pCLE guided evaluation	Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)
Standard endoscopic evaluation	Standard endoscopic evaluation	Standard high-definition white light endoscopy guided evaluation

Primary Outcome Measures

Name	Time	Method
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"	3 month follow-up endoscopic procedure	Number of Barrett's Esophagus (BE) Participants with a Composite Outcome of "Optimally Treated", in each group defined as patients for whom all lesions are ablated when disease is present, or not ablated when disease is absent, or have complete ablation of all disease at the 3 month follow-up.

Secondary Outcome Measures

Name	Time	Method

Locations (6): University of Chicago Hospital
🇺🇸
Chicago, Illinois, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Veterans Affairs Hospital
🇺🇸
Kansas City, Missouri, United States
Centre Hospitalier Universitaire
🇫🇷
Nantes, France
University College London Hospital
🇬🇧
London, United Kingdom
Mayo Clinic
🇺🇸
Jacksonville, Florida, United States