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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-04-30

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.

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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.

Conditions

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Barrett Syndrome Barrett's Syndrome Barrett's Esophagus Barrett Esophagus Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard endoscopic evaluation

Standard high-definition white light endoscopy guided evaluation

Group Type ACTIVE_COMPARATOR

Standard endoscopic evaluation

Intervention Type DEVICE

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

pCLE-guided evaluation

Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)

Group Type EXPERIMENTAL

pCLE guided evaluation

Intervention Type DEVICE

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.

Interventions

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Standard endoscopic evaluation

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

Intervention Type DEVICE

pCLE guided evaluation

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No