Clinical trial · Interventional
Novel Imaging Techniques in Barrett's Esophagus
Detection Of Intestinal Metaplasia And High Grade Dysplasia In Barrett's Esophagus Using Novel Imaging Techniques - A Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Aim: In patients with endoscopically suspected BE, compared to standard endoscopy, novel techniques (NBI and AFI) with target biopsies will * Detect more patients with intestinal metaplasia * Detect more areas of high grade dysplasia * Require fewer biopsies and a shorter time for procedure completion Secondary Aim: * Compare the yield of high-grade dysplasia(HGD)using NBI/AFI versus standard endoscopy with biopsy. * Compare the number of biopsies and procedure times for NBI/AFI versus standard endoscopy with biopsy. * Compare the inter-observer variability in classifying different mucosal and vascular patterns observed by NBI/AFI using kappa statistics.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Gastroesophageal Reflux | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NBI-AFI imaging | Other | — | UNRESOLVED |
| Standard Endoscopy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1- Narrow Band Imaging
- description
- NBI-AFI imaging - Narrow Band Imaging- Patients will be evaluated with a standard magnification endoscope (Olympus GIF Q240Z, 115x or GIF-H180 or equivalent) using a NBI light source. Autofluorescence Imaging (AFI)- Patients will be evaluated using a prototype autofluorescence endoscope (Olympus, Tokyo, Japan; excitation 395-475 nm, fluorescence detection 490-625 nm, red reflectance 600-620 nm and green reflectance 540-560 nm)
- interventionNames
- Other: NBI-AFI imaging
- type
- OTHER
- label
- 2-Standard Endoscopy
- description
- Standard Endoscopy- Patients will undergo EGD with biopsies using a standard diagnostic video endoscope (Olympus, GIF 140 or 160) using the Seattle protocol - 4 quadrant biopsies using standard biopsy forceps every 2 cms; stored in separate jars
- interventionNames
- Other: Standard Endoscopy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with suspected Barrett's esophagus on endoscopy * Age \> 18 years * Ability to provide written informed consent Exclusion Criteria: * Presence of erosive esophagitis * Visible nodules, lesions within Barrett's esophagus segment * Endoscopist aware of biopsy results * Inability to obtain biopsies due to anticoagulation or varices
References
Publications (12)
- BACKGROUNDWeinstein WM, Ippoliti AF. The diagnosis of Barrett's esophagus: goblets, goblets, goblets. Gastrointest Endosc. 1996 Jul;44(1):91-5. doi: 10.1016/s0016-5107(96)70239-0. No abstract available. PMID 8836727
- BACKGROUNDDevesa SS, Blot WJ, Fraumeni JF Jr. Changing patterns in the incidence of esophageal and gastric carcinoma in the United States. Cancer. 1998 Nov 15;83(10):2049-53. PMID 9827707
- BACKGROUNDBrown LM, Devesa SS. Epidemiologic trends in esophageal and gastric cancer in the United States. Surg Oncol Clin N Am. 2002 Apr;11(2):235-56. doi: 10.1016/s1055-3207(02)00002-9. PMID 12424848
- BACKGROUNDGerson LB, Shetler K, Triadafilopoulos G. Prevalence of Barrett's esophagus in asymptomatic individuals. Gastroenterology. 2002 Aug;123(2):461-7. doi: 10.1053/gast.2002.34748. PMID 12145799
- BACKGROUNDRex DK, Cummings OW, Shaw M, Cumings MD, Wong RK, Vasudeva RS, Dunne D, Rahmani EY, Helper DJ. Screening for Barrett's esophagus in colonoscopy patients with and without heartburn. Gastroenterology. 2003 Dec;125(6):1670-7. doi: 10.1053/j.gastro.2003.09.030. PMID 14724819
- BACKGROUNDHamilton SR, Smith RR, Cameron JL. Prevalence and characteristics of Barrett esophagus in patients with adenocarcinoma of the esophagus or esophagogastric junction. Hum Pathol. 1988 Aug;19(8):942-8. doi: 10.1016/s0046-8177(88)80010-8. PMID 3402983
- BACKGROUNDSampliner RE. Practice guidelines on the diagnosis, surveillance, and therapy of Barrett's esophagus. The Practice Parameters Committee of the American College of Gastroenterology. Am J Gastroenterol. 1998 Jul;93(7):1028-32. doi: 10.1111/j.1572-0241.1998.00362.x. No abstract available. PMID 9672324
- Sharma P, McQuaid K, Dent J, Fennerty MB, Sampliner R, Spechler S, Cameron A, Corley D, Falk G, Goldblum J, Hunter J, Jankowski J, Lundell L, Reid B, Shaheen NJ, Sonnenberg A, Wang K, Weinstein W; AGA Chicago Workshop. A critical review of the diagnosis and management of Barrett's esophagus: the AGA Chicago Workshop. Gastroenterology. 2004 Jul;127(1):310-30. doi: 10.1053/j.gastro.2004.04.010.