Barrett's Esophagus, Esophageal Intraepithelial Neoplasia Clinical Trial
— CEBEOfficial title:
In Vivo Endomicroscopy (EM) for Improved Diagnosis of Barrett's Esophagus (BE) and Associated Neoplasia: A Multicenter Randomized Controlled Trial of Diagnostic Yield and Clinical Impact
| NCT number | NCT01124214 |
| Other study ID # | NA_00025471 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 2010 |
| Est. completion date | June 2013 |
| Verified date | May 2023 |
| Source | Johns Hopkins University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Endomicroscopy (EM) can improve the diagnosis Barrett's esophagus (BE) and some early esophageal cancers (Intra Epithelial Neoplasia (IEN)). EM provides optical biopsies comparable to standard histology. Specifically, EM allows targeted biopsy rather than random mucosal biopsy during routine endoscopic surveillance of BE or evaluation EIN, which will improve the diagnostic yield of mucosal samples for BE IEN. Furthermore, when combined with high resolution endoscopy, EM may improve the overall in vivo detection of IEN in lesions as well as flat mucosa. EM will provide accurate place and size of IEN which will impact the physician's decision to biopsy or perform endoscopic mucosal resection (EMR). This could potentially minimize the number of unnecessary biopsies and as well as enable the physician to perform EMR at the time of the initial examination, rather than delaying endoscopic treatment after the pathology is available. This study is important because it will validate single center studies supporting the routine use of EM for screening and surveillance of BE.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | June 2013 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - Surveillance of Barrett's esophagus or suspected or known BE associated neoplasia Exclusion Criteria: - Allergy or prior reaction to the fluorescent contrast agent fluorescein sodium - Unable to give informed consent. - Pregnant or breastfeeding women - Known advanced adenocarcinoma in the esophagus - Dysplastic or suspected malignant esophageal lesion 0 BE lesions 2 cm or more in size with Paris classification of 0-Ip (polypoid), 0-Is (protruding sessile), 0-IIa (flat elevated), or 0-IIb (flat) - Lesions of any size with Paris 0-IIc (superficial shallow depressed) or 0-III (excavated) - Acute gastrointestinal bleeding - Coagulopathy defined by Partial Thromboplastin Time (PTT) > 50 sec, or International Normalized Ratio (INR) > 2.0, platelets < 40,000, or on chronic anticoagulation - Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy. - History of a severe allergic reaction (anaphylaxis) - Known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Johannes Gutenberg - University of Mainz | Mainz | |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Mount Sinai School of Medicine | New York | New York |
| United States | University of Pennsylvania Medical Institution | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Johns Hopkins University | American Society for Gastrointestinal Endoscopy, Pentax Medical Corporation |
United States, Germany,
Canto MI, Anandasabapathy S, Brugge W, Falk GW, Dunbar KB, Zhang Z, Woods K, Almario JA, Schell U, Goldblum J, Maitra A, Montgomery E, Kiesslich R; Confocal Endomicroscopy for Barrett's Esophagus or Confocal Endomicroscopy for Barrett's Esophagus (CEBE) Trial Group. In vivo endomicroscopy improves detection of Barrett's esophagus-related neoplasia: a multicenter international randomized controlled trial (with video). Gastrointest Endosc. 2014 Feb;79(2):211-21. doi: 10.1016/j.gie.2013.09.020. Epub 2013 Nov 9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | compare diagnostic yield | Compare the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRE plus EM with directed biopsy (HRE-EM-DB) over HRE with directed biopsy of all mucosal lesions followed by random biopsy (HRE-DB-RB) to diagnose BE in flat mucosa and mucosal lesions
The mean diagnostic yield for IEN will be calculated (number of mucosal biopsies and EMR specimens with High Grade Dysplasia (HGD) or Carcinoma (CA) divided by total number of mucosal biopsies obtained) by group and compared, using a chi square or Fisher's exact test for independent groups, depending on the distribution of the data. |
1 year | |
| Secondary | assess clinical impact of EM | To prospectively assess the potential clinical impact of EM on the diagnosis and endoscopic surveillance of BE by determining if EM alters the decision to biopsy or EMR and change the total of biopsies per procedure. | 1 year | |
| Secondary | compare the specificity and sensitivity of HRE with EM | To compare the performance (sensitivity and specificity) characteristics of HRE-EM-DB with HRE-RB for prediction of BE/IEN using the pathologic diagnosis of mucosal biopsies the as the reference standard. | 1 year |