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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Barrett Syndrome, Barrett's Syndrome, Barrett's Esophagus, Barrett Esophagus, Adenocarcinoma

Intervention / Treatment
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* Device: Standard endoscopic evaluation
* Device: pCLE guided evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard endoscopic evaluation<br>Standard high-definition white light endoscopy guided evaluation | Device: Standard endoscopic evaluation<br>* Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy<br>|
| Experimental: pCLE-guided evaluation<br>Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation) | Device: pCLE guided evaluation<br>* Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of Optimally Treated | 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. | 3 month follow-up endoscopic procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barrett's esophagus, EsoGastroDuodenoscopy, Barrett's carcinoma, adenocarcinoma, Cellvizio, endomicroscopy, probe-based Confocal Laser Endomicroscopy, pCLE, Radio-frequency ablation, Endoscopic mucosal resection, Photodynamic therapy