Adenocarcinoma, Barrett Esophagus, Barrett's Esophagus, Barrett's Syndrome, Barrett Syndrome
Conditions
Keywords
Barrett's esophagus, EsoGastroDuodenoscopy, Barrett's carcinoma, adenocarcinoma, Cellvizio, endomicroscopy, probe-based Confocal Laser Endomicroscopy, pCLE, Radio-frequency ablation, Endoscopic mucosal resection, Photodynamic therapy
Brief summary
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
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.
Interventions
Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
DEVICEpCLE 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.
Sponsors
Cellvizio Inc.
Mauna Kea Technologies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of Optimally Treated | 3 month follow-up endoscopic procedure | 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. |
Countries
France, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Endoscopic Evaluation Standard high-definition white light endoscopy guided evaluation
Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy | 82 |
| pCLE-guided 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. | 82 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 11 | 11 |
| Overall Study | Protocol Violation | 14 | 8 |
Baseline characteristics
| Characteristic | Standard Endoscopic Evaluation | pCLE-guided Evaluation | Total |
|---|---|---|---|
| Age, Continuous | 67.9 years | 69.6 years | 68.8 years |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 78 Participants | 75 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 82 | 0 / 82 |
| serious Total, serious adverse events | 0 / 82 | 1 / 82 |
Outcome results
Primary
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
Population: Among the 141 patients who completed the initial procedure, 119 had follow-up visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Endoscopic Evaluation | Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of Optimally Treated | 16 participants |
| pCLE-guided Evaluation | Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of Optimally Treated | 16 participants |