Endoscopic Techniques for Barrett's Esophagus
(BERN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to detect and treat early signs of esophageal cancer in individuals with Barrett's esophagus, a condition where the esophagus lining changes and can lead to cancer. It tests advanced imaging tools and procedures, such as Chromoendoscopy (including Virtual Chromoendoscopy, Narrow-Band Imaging, Fujinon Intelligent Chromo-Endoscopy, and Pentax I-scan), to help doctors identify and treat problem areas more accurately. Individuals with Barrett's esophagus who are scheduled for an endoscopy might be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in early cancer detection.
Will I have to stop taking my current medications?
If you are currently taking aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or chronic anticoagulants, you will need to stop these medications before the procedure.
What prior data suggests that these endoscopic techniques are safe for detecting Barrett's esophagus and early neoplasia?
Research has shown that the treatments used in this trial are generally safe for people.
For chromoendoscopy, studies have found that it helps doctors see blood vessel patterns more clearly without major safety concerns. Electronic chromoendoscopy, a newer version, enhances image quality while maintaining the safety of the traditional method.
Endoscopic Mucosal Resection (EMR) is considered quite safe, with low rates of bleeding and perforation, usually below 1%. In rare cases, complications like perforation can occur, but they are often successfully treated during the procedure.
High Resolution Endoscopy (HRE) is widely used and very safe, with no known complications directly linked to high-resolution endoscopes.
Narrow Band Imaging (NBI) is a non-invasive method that improves tissue visibility. It has been used extensively without major safety issues, making it a reliable tool for identifying suspicious areas.
Overall, these treatments are well-tolerated, with studies reporting low rates of side effects.12345Why are researchers excited about this trial?
Researchers are excited about these techniques for Barrett's Esophagus because they offer enhanced detection and treatment precision. Chromoendoscopy uses special dyes to highlight abnormal cells, which may allow doctors to spot early signs of cancer more effectively than standard white-light endoscopy. High Resolution Endoscopy (HRE) and Narrow Band Imaging (NBI) provide clearer, more detailed views of the esophageal lining, potentially leading to better diagnosis and treatment outcomes. Endoscopic Mucosal Resection (EMR) allows for the removal of abnormal tissue in a minimally invasive way, which may reduce the need for surgery. These technologies together could revolutionize how we detect and manage early esophageal cancer, improving patient outcomes significantly.
What evidence suggests that these endoscopic techniques are effective for detecting Barrett's esophagus and early neoplasia?
Research has shown that chromoendoscopy effectively spots and assesses the depth of abnormal tissue during endoscopies. It is considered a top method for improving detection rates. Endoscopic mucosal resection (EMR) effectively removes flat colorectal lesions, achieving a high success rate for complete removal. High-resolution endoscopy (HRE) aids in lesion detection by providing clearer images. Narrow band imaging (NBI) has shown promising results in identifying early-stage cancers by offering more accurate and sensitive images. Together, these methods enhance the detection and treatment of abnormal growths related to Barrett's esophagus.13678
Who Is on the Research Team?
Prateek Sharma, MD
Principal Investigator
Kansas City VA Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Endoscopic Procedure
Standard endoscopy followed by high-resolution endoscopy, narrow band imaging, and chromoendoscopy. Digital video-recording of endoscopy findings and target biopsies of suspected lesions.
Treatment
Removal of abnormal lesions with endoscopic mucosal resection or mucosal ablation.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pathologic and clinical outcomes.
What Are the Treatments Tested in This Trial?
Interventions
- Chromoendoscopy
- Endoscopic Mucosal Resection (EMR)
- High Resolution Endoscopy (HRE)
- Narrow Band Imaging (NBI)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Midwest Biomedical Research Foundation
Lead Sponsor
Kansas City Veteran Affairs Medical Center
Collaborator
Citations
Electronic chromo-endoscopy: technical details and a clinical ...
Electronic chromoendoscopy has helped in identifying, delineating and assessing the depth of the lesions in the routine endoscopies at the switch of a button, ...
NCT01882205 | Comparison Between Chromoendoscopy ...
Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic ...
Narrow-band imaging versus I-Scan for the real-time ...
Diagnostic efficacies of NBI and I-Scan. Results. NBI and I-Scan displayed a significantly higher sensitivity and improved accuracy compared with high- ...
Comparison Between Chromoendoscopy and Virtual ...
Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic ...
Comparative Study of Narrow-Band Imaging and i-scan for ...
The combination of magnifying colonoscopy and dye-spray chromoendoscopy has been reported to be reliable for distinguishing colorectal neoplasms ...
i-SCAN - Virtual chromoendoscopy
The i-SCAN technology provides extra visual information for a more accurate in vivo diagnosis through improved vessel and mucosal pattern characterization.
Electronic chromoendoscopy
The term electronic chromoendoscopy refers to endo- scopic imaging technologies that provide detailed contrast enhancement of the mucosal surface and blood ...
Comparative Efficacy and Safety of Endoscopic Modalities ...
HD dye-based chromoendoscopy may improve dysplasia detection compared with other modalities like HD white light endoscopy, although evidence certainty is low.
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