Trial Outcomes & Findings for CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia (NCT NCT01032044)
NCT ID: NCT01032044
Last Updated: 2016-04-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
164 participants
Primary outcome timeframe
3 month follow-up endoscopic procedure
Results posted on
2016-04-22
Participant Flow
Participant milestones
| Measure |
Standard Treatment
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
|
pCLE-guided 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.
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
82
|
|
Overall Study
Procedure
|
74
|
75
|
|
Overall Study
COMPLETED
|
57
|
62
|
|
Overall Study
NOT COMPLETED
|
25
|
20
|
Reasons for withdrawal
| Measure |
Standard Treatment
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
|
pCLE-guided 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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
14
|
8
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
11
|
11
|
Baseline Characteristics
CLE for Assessment of Neoplasia After Mucosal Ablation or Resection of Gastrointestinal Neoplasia
Baseline characteristics by cohort
| Measure |
Standard Endoscopic Evaluation
n=82 Participants
Standard high-definition white light endoscopy guided evaluation
Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
|
pCLE-guided Evaluation
n=82 Participants
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.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
n=5 Participants
|
69.6 years
n=7 Participants
|
68.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 month follow-up endoscopic procedurePopulation: Among the 141 patients who completed the initial procedure, 119 had follow-up visits.
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.
Outcome measures
| Measure |
Standard Endoscopic Evaluation
n=57 Participants
Standard high-definition white light endoscopy guided evaluation
Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy
|
pCLE-guided Evaluation
n=62 Participants
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.
|
|---|---|---|
|
Number of Barrett's Esophagus (BE) Participants With a Composite Outcome of "Optimally Treated"
|
16 participants
|
16 participants
|
Adverse Events
Standard Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
pCLE-guided Treatment
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Treatment
n=82 participants at risk
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
|
pCLE-guided Treatment
n=82 participants at risk
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.
|
|---|---|---|
|
Immune system disorders
Intolerance to Fluorescein
|
0.00%
0/82 • from inclusion to 3 months follow-up visit post-procedure
|
1.2%
1/82 • Number of events 1 • from inclusion to 3 months follow-up visit post-procedure
|
Other adverse events
Adverse event data not reported
Additional Information
Dr Michael B. Wallace
Mayo Clinic, Jacksonville, Florida, USA
Phone: 904 953-7630
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place