Gastroesophageal Reflux Clinical Trial
Official title:
Detection Of Intestinal Metaplasia And High Grade Dysplasia In Barrett's Esophagus Using Novel Imaging Techniques - A Randomized Controlled Trial.
Verified date | October 2012 |
Source | Midwest Biomedical Research Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Netherlands | Academisch Medisch Centrum-Universiteit van Amsterdam (AMC-UvA) | Amsterdam | |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Veterans Affairs Medical Center | Kansas city | Missouri |
Lead Sponsor | Collaborator |
---|---|
Midwest Biomedical Research Foundation | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Kansas City Veteran Affairs Medical Center, Medical University of South Carolina |
United States, Netherlands,
Brown 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. Review. — View Citation
Cameron AJ, Carpenter HA. Barrett's esophagus, high-grade dysplasia, and early adenocarcinoma: a pathological study. Am J Gastroenterol. 1997 Apr;92(4):586-91. — View Citation
Devesa 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. — View Citation
Eloubeidi MA, Provenzale D. Does this patient have Barrett's esophagus? The utility of predicting Barrett's esophagus at the index endoscopy. Am J Gastroenterol. 1999 Apr;94(4):937-43. — View Citation
Gerson LB, Shetler K, Triadafilopoulos G. Prevalence of Barrett's esophagus in asymptomatic individuals. Gastroenterology. 2002 Aug;123(2):461-7. — View Citation
Hamilton 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. — View Citation
Inadomi JM, Sampliner R, Lagergren J, Lieberman D, Fendrick AM, Vakil N. Screening and surveillance for Barrett esophagus in high-risk groups: a cost-utility analysis. Ann Intern Med. 2003 Feb 4;138(3):176-86. — View Citation
Rex 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. — View Citation
Sampliner 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. — View Citation
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. Review. — View Citation
Weinstein WM, Ippoliti AF. The diagnosis of Barrett's esophagus: goblets, goblets, goblets. Gastrointest Endosc. 1996 Jul;44(1):91-5. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with biopsy confirmed intestinal metaplasia | 08/2006 to 10/2008 | No | |
Secondary | Detection of high grade dysplasia | 08/2006 to 10/2008 | No | |
Secondary | Procedure time | 08/2006 to 10/2008 | No | |
Secondary | Number of biopsies | 08/2006 to 10/2008 | No | |
Secondary | Inter observer variability in reading of mucosal and vascular patterns | 08/2006 to 10/2008 | No |
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