Trial Outcomes & Findings for Confocal Endomicroscopy for Barrett's Esophagus (NCT NCT00487695)

NCT ID: NCT00487695

Last Updated: 2021-06-22

Results Overview

The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 46 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2021-06-22

Participant Flow

Recruited from April 2007 to May 2008 from the gastroenterology clinics at Johns Hopkins University.

None of the patients enrolled were excluded prior to group assignment. 1 patient dropped out prior to the first procedure.

Participant milestones

Measure	CLE Followed by Standard EGD Patients randomized to either CLE or standard endoscopy first. The other procedure was then performed 6 weeks later. This group was randomized to CLE first, followed by standard endoscopy	Standard EGD Followed by CLE Patients in this group were randomized to have standard EGD followed by CLE 6 weeks later
First Procedure STARTED	23	23
First Procedure COMPLETED	20	23
First Procedure NOT COMPLETED	3	0
Second Procedure STARTED	20	23
Second Procedure COMPLETED	19	20
Second Procedure NOT COMPLETED	1	3

Reasons for withdrawal

Measure	CLE Followed by Standard EGD Patients randomized to either CLE or standard endoscopy first. The other procedure was then performed 6 weeks later. This group was randomized to CLE first, followed by standard endoscopy	Standard EGD Followed by CLE Patients in this group were randomized to have standard EGD followed by CLE 6 weeks later
First Procedure invasive cancer on EGD (excl criteria)	1	0
First Procedure active wheezing (did not have procedure)	1	0
First Procedure esophageal stricture found (excl crit)	1	0
Second Procedure active wheezing	0	1
Second Procedure Withdrawal by Subject	1	2

Baseline Characteristics

Confocal Endomicroscopy for Barrett's Esophagus

Baseline characteristics by cohort

Measure	All Study Participants n=46 Participants Patients received both procedures (CLE and standard EGD), so baseline characteristics are reported for the group
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	63.8 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed. This analysis looks specifically at patients with Barrett's and suspected (but not known) neoplasia.

The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)

Outcome measures

Measure	Confocal Laser Endomicroscopy n=16 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.	Standard Endoscopy n=16 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)	34 percent yield for neoplasia 0	17 percent yield for neoplasia 0

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.

The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients with Barrett's suspected (but not known) neoplasia.

Outcome measures

Measure	Confocal Laser Endomicroscopy n=16 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.	Standard Endoscopy n=16 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)	3.1 mean number of biopsies with neoplasia Interval 0.0 to 15.0	3.7 mean number of biopsies with neoplasia Interval 0.0 to 19.0

SECONDARY outcome

Timeframe: 6 weeks

Population: per protocol as participants would only have data to compare if they completed both endoscopies

The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the Barrett's patients with suspected (but not known) neoplasia.

Outcome measures

Measure	Confocal Laser Endomicroscopy n=16 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.	Standard Endoscopy n=16 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia)	9.8 mean number of biopsies Interval 1.0 to 22.0	23.7 mean number of biopsies Interval 3.0 to 41.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was per protocol as the patients who did not undergo CLE could not be analyzed at all (cannot compare 2 procedures when only one (or zero) are performed).

Our hypothesis was that the yield for neoplasia would be higher using confocal laser endomicroscopy compared to standard endoscopy. The null hypothesis would be that there is no difference in yield for neoplasia when CLE is used compared to standard endoscopy. This analysis looks specifically at patients who were referred for surveillance of Barrett's esophagus (no suspected neoplasia).

Outcome measures

Measure	Confocal Laser Endomicroscopy n=23 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.	Standard Endoscopy n=23 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients	0 percent yield for neoplasia	0 percent yield for neoplasia

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was per protocol. Each participant was compared to self, so if the participant did not complete the study, no comparison could be made.

The number of biopsies from each procedure (i.e. biopsies taken during CLE, or biopsies taken during standard EGD) that showed neoplasia. Neoplasia is high grade dysplasia or cancer. This analysis looks at patients undergoing surveillance EGD for Barrett's esophagus (no suspected neoplasia).

Outcome measures

Measure	Confocal Laser Endomicroscopy n=23 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.	Standard Endoscopy n=23 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients	0 number of biopsies with neoplasia Interval 0.0 to 0.0	0 number of biopsies with neoplasia Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 6 weeks

Population: Analysis was per protocol. Each participant was compared to self, so if the participant did not complete, the study, no comparison could be made. The patients in this analysis were referred for surveillance of Barrett's esophagus (no suspected neoplasia).

The number of biopsies taken during each procedure (i.e. the number of biopsies taken during CLE, or the number of biopsies taken during standard EGD). Biopsies are taken during CLE only if CLE shows that the esophageal mucosa is abnormal. Esophageal biopsies are taken during standard EGD using a standard Barrett's esophagus protocol (4 quadrants, every 1-2 cm of the Barrett's esophagus). This analysis looks at the patients with Barrett's esophagus in the study who were undergoing surveillance EGD (no suspected neoplasia).

Outcome measures

Measure	Confocal Laser Endomicroscopy n=23 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.	Standard Endoscopy n=23 Participants all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
Mean Number of Biopsies Taken in Barrett's Surveillance Patients	1.7 mean number of biopsies Interval 0.0 to 12.0	12.6 mean number of biopsies Interval 1.0 to 28.0

Adverse Events

Confocal Laser Endomicroscopy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard EGD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Confocal Laser Endomicroscopy n=39 participants at risk Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)	Standard EGD n=39 participants at risk Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
Infections and infestations post-procedure pneumonia	2.6% 1/39 • Number of events 1 • Adverse event data was collected after each procedure and for an average of one month after the last procedure.	0.00% 0/39 • Adverse event data was collected after each procedure and for an average of one month after the last procedure.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marcia Canto.

Johns Hopkins University School of Medicine Division of Gastroenterology and Hepatology

Phone: 410-614-5388

Email: mcanto@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place