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

Confocal Laser Endomicroscopy for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia

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.

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.

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:

• Participation in another clinical study
• Circumferential BE
• Complete eradication of BE documented by biopsies
• Inability to obtain biopsies due to anticoagulation, varices, etc.
• Allergy to fluorescein
• Pregnancy
• Renal insufficiency