Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Carcinoma

Adenocarcinoma

Syndrome

Barrett Esophagus

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.

Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order.

Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete.

Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed.

After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.

Imaging procedures (NBI)

HDWLE

pCLE

Prateek Sharma, MD

This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and specificity to a level that would be acceptable to avoid random biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings of standard white light endoscopy (high number of random biopsies, less than ideal directed biopsy of suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity with resultant high false positives, again resulting in many unnecessary biopsies).

Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

Cellvizio Inc.

Emissary International LLC

Mauna Kea Technologies

Group 1

Age, Continuous

Sex: Female, Male

France

United States

Germany

Region of Enrollment

Christophe Bailleul

Sensitivity

Specificity

NBI (Narrow Band Imaging)

HDWLE+NBI+pCLE

HDWLE+pCLE

HDWLE+NBI

Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

HDWLE First NBI Second and pCLE

NBI First HDWLE Second and pCLE

Overall Study

Standard high-definition white light endoscopy guided evaluation

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

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

Standard endoscopic 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.

pCLE guided evaluation

Michael Wallace, MD

Anne Osdoit

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.

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

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.

Standard high-definition white light endoscopy guided treatment

Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy

Standard Treatment

Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy

pCLE guided endoscopic treatment of BE: 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.

pCLE-guided Treatment

Standard high-definition white light endoscopy guided evaluation

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

Standard Endoscopic Evaluation

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

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.

pCLE-guided Evaluation

Total

Exploratory analysis of the data according to the intent-to-treat principle resulted in no suggestion of systematic bias in the two groups regarding withdrawals. Only 1 patient was withdrawn because of intolerance to fluorescein.

Dr Michael B. Wallace

Among the 141 patients who completed the initial procedure, 119 had follow-up visits.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy	NCT00795184	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Imaging procedu... HDWLE pCLE	18 Years -	Mauna Kea Technologies
Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy	NCT00795184	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Imaging procedu... HDWLE pCLE	18 Years -	Mauna Kea Technologies
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia	NCT01032044	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Standard endosc... pCLE guided eva...	18 Years -	Mauna Kea Technologies
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia	NCT01032044	Barrett Syndrom... Barrett's Syndr... Barrett's Esoph... Barrett Esophag... Adenocarcinoma	Standard endosc... pCLE guided eva...	18 Years -	Mauna Kea Technologies

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