A Phase 3 interventional study of confocal laser endomicroscopy (CLE) and standard endoscopy (EGD) in Barrett's Esophagus and Esophageal Adenocarcinoma, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-22.
Sponsored by Johns Hopkins University · Phase 3, Interventional, and Diagnostic
The purpose of this study is to determine if confocal laser endomicroscopy (CLE) can improve detection of Barrett's esophagus, dysplasia, and early esophageal cancer.
Barrett's esophagus is a leading cause of esophageal adenocarcinoma. Detection of dysplasia and early cancers in Barrett's esophagus can be challenging, time-consuming and expensive. Small lesions may be difficult to detect with standard endoscopy protocols. Confocal laser endomicroscopy (CLE) is a new type of endoscopy where a small confocal microscope is built into the tip of a standard endoscope. For this study, we are comparing confocal laser endomicroscopy (CLE) with targeted biopsies with standard endoscopy (EGD)and biopsy for Barrett's esophagus to determine if CLE is more effective for detecting dysplasia and cancer.
Participants with Barrett's esophagus in this study undergo 1) CLE with targeted mucosal biopsies (biopsy only taken if CLE shows abnormal tissue) and 2) standard EGD with biopsies. The order of procedures is randomized (some patients have CLE first while others have standard EGD first).
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 46 is close to the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
Participants are randomized to have either confocal laser endomicroscopy (CLE) or standard endoscopy (EGD) first. Then 6 weeks later, they have the other procedure. This arm is for patients randomized to CLE followed by standard EGD
Device: confocal laser endomicroscopy (CLE) · Device: standard endoscopy (EGD)
Patients are randomized to either have standard endoscopy (EGD)or confocal laser endomicroscopy (CLE) first. The second procedure is then completed 6 weeks later. This arm is for patients who had standard endoscopy first.
Device: confocal laser endomicroscopy (CLE) · Device: standard endoscopy (EGD)
Confocal laser endomicroscopy is done by performing standard endoscopy, then using a microscope on the tip of the endoscope to obtain microscopic images of the mucosa. This is done by gently placing the tip of the endoscope on the lining of the esophagus.
Also known as: Pentax Confocal Laser Endomicroscope(EC3870KCILK)
Standard upper endoscopy (EGD) is performed using a regular upper endoscope, which is used to look at the lining of the esophagus.
Also known as: Olympus upper endoscope (GIF160)
Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia)
The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)
Time frame: 6 weeks
Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia)
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.
Time frame: 6 weeks
Mean Number of Biopsies Taken in High Risk Patients (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 Barrett's patients with suspected (but not known) neoplasia.
Time frame: 6 weeks
Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients
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).
Time frame: 6 weeks
Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients
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).
Time frame: 6 weeks
Mean Number of Biopsies Taken in Barrett's Surveillance Patients
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).
Time frame: 6 weeks
Recruited from April 2007 to May 2008 from the gastroenterology clinics at Johns Hopkins University.
| Milestone | CLE Followed by Standard EGD | Standard EGD Followed by CLE |
|---|---|---|
| Started | 23 | 23 |
| Completed | 20 | 23 |
| Not completed | 3 | 0 |
| Withdrew: Invasive cancer on egd (excl criteria) | 1 | 0 |
| Withdrew: Active wheezing (did not have procedure) | 1 | 0 |
| Withdrew: Esophageal stricture found (excl crit) | 1 | 0 |
| Milestone | CLE Followed by Standard EGD | Standard EGD Followed by CLE |
|---|---|---|
| Started | 20 | 23 |
| Completed | 19 | 20 |
| Not completed | 1 | 3 |
| Withdrew: Active wheezing | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
The yield for neoplasia is calculated by the number of biopsies showing neoplasia over the total number of biopsies taken (normal + neoplastic biopsies)
| percent yield for neoplasia | Confocal Laser Endomicroscopy | Standard Endoscopy |
|---|---|---|
| Diagnostic Yield for Neoplasia in High Risk Patients(Suspected Neoplasia) | 34 ± 0 | 17 ± 0 |
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.
| mean number of biopsies with neoplasia | Confocal Laser Endomicroscopy | Standard Endoscopy |
|---|---|---|
| Mean Number of Biopsies With Neoplasia in High Risk Patients (Suspected Neoplasia) | 3.1 (0 to 15) | 3.7 (0 to 19) |
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.
| mean number of biopsies | Confocal Laser Endomicroscopy | Standard Endoscopy |
|---|---|---|
| Mean Number of Biopsies Taken in High Risk Patients (Suspected Neoplasia) | 9.8 (1 to 22) | 23.7 (3 to 41) |
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).
| percent yield for neoplasia | Confocal Laser Endomicroscopy | Standard Endoscopy |
|---|---|---|
| Diagnostic Yield for Neoplasia in Barrett's Surveillance Patients | 0 | 0 |
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).
| number of biopsies with neoplasia | Confocal Laser Endomicroscopy | Standard Endoscopy |
|---|---|---|
| Mean Number of Biopsies With Neoplasia in Barrett's Surveillance Patients | 0 (0 to 0) | 0 (0 to 0) |
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).
| mean number of biopsies | Confocal Laser Endomicroscopy | Standard Endoscopy |
|---|---|---|
| Mean Number of Biopsies Taken in Barrett's Surveillance Patients | 1.7 (0 to 12) | 12.6 (1 to 28) |
Collected over Adverse event data was collected after each procedure and for an average of one month after the last procedure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Confocal Laser Endomicroscopy | — | 1/39 (2.6%) | 0/39 (0%) |
| Standard EGD | — | 0/39 (0%) | 0/39 (0%) |
| Event | Confocal Laser Endomicroscopy | Standard EGD |
|---|---|---|
| post-procedure pneumoniaInfections and infestations | 1/39 | 0/39 |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 25 |
| >=65 years | 21 |
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 63.8 ± 9.3 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 12 |
| Male | 34 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 46 |
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