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

N/ACompletedNCT01032044

Mauna Kea Technologies164 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

164

Conditions

Barrett Syndrome Barrett's Syndrome Barrett's Esophagus

Interventions

Standard endoscopic evaluationDEVICE

Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

pCLE guided evaluationDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Mayo Clinic

Jacksonville, Florida, United States

University of Chicago Hospital

Chicago, Illinois, United States

Veterans Affairs Hospital

Kansas City, Missouri, United States

University of Washington Medical Center

Seattle, Washington, United States

Centre Hospitalier Universitaire

Nantes, France

University College London Hospital

London, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: 3 month follow-up endoscopic procedure