Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282672
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2006-01-25
Brief Title:
Ablation of Intestinal Metaplasia Containing Dysplasia
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
Ablation of Intestinal Metaplasia Containing Dysplasia AIM Dysplasia Trial A Multi-center Randomized Sham-Controlled Trial Protocol Amendment to Extend Follow-up to 5 Years
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if the intervention of a 510k-cleared endoscopically-guided Halo Ablation systems ablation system plus anti-secretory therapy is better than anti-secretory therapy alone in clearing Barretts Esophagus
Detailed Description:
Barretts esophagus or intestinal metaplasia IM is a change in the epithelial lining of the esophagus Barretts esophagus develops as a result of chronic exposure of the esophagus to refluxed stomach acid and enzymes as well as bile resulting in recurrent mucosal injury Injury is accompanied by inflammation and ultimately a cellular change metaplasia to a specialized columnar epithelium Spechler SJ Barretts Esophagus N Engl J Med 200234611836-842
Patients who have a diagnosis of Barretts esophagus typically undergo surveillance endoscopy every 1-3 years with multiple biopsy specimens obtained to facilitate early detection of progression of IM to dysplasia more severe precancerous changes and adenocarcinoma Sampliner RE Updated guidelines for the diagnosis surveillance and therapy of Barretts esophagus Am J Gastro 2002971888-1895 Progression of IM to low-grade dysplasia LGD indicates that cells exhibit more cancer-like architecture thus warranting an accelerated surveillance endoscopy and biopsy program every 6 months rather than every 1-3 years as indicated for non-dysplastic IM Progression to high-grade dysplasia HGD indicates that the cells are even more cancer-like thus warranting an even higher frequency surveillance endoscopy and biopsy program every 3 months Many HGD patients may undergo photodynamic therapy PDT or surgical esophagectomy rather than remain in a frequent surveillance program This more aggressive therapy is warranted because of the high rate of progression of HGD to adenocarcinoma
Esophageal adenocarcinoma most commonly occurs after an insidious progression from IM to LGD to HGD Therefore surveillance is increased upon diagnosis of worsening grades of dysplasia The incidence of esophageal adenocarcinoma is rapidly increasing as middle-aged and elderly demographic sub-groups expand Peters JH Hagen JA DeMeester SR Barretts Esophagus J Gastrointest Surg 2004811-17 In 2004 the American Cancer Society reported that there were 14250 new cases of esophageal cancer and 13300 deaths attributable to esophageal cancer wwwcancerorg The US National Cancer Institute Surveillance Epidemiology and End Results Program reported that the increasing incidence of esophageal adenocarcinoma was greater than for any other cancer in the United States wwwcancergov
Elimination of the diseased epithelium containing IM with dysplasia is an intuitively favorable step for patients with this diagnosis In other disease states such as colon polyps or premalignant skin lesions removal of the premalignant tissue results in a reduction in the risk of ultimately developing cancer This is a logical conclusion when considering the premalignant lesion of Barretts esophagus particularly Barretts esophagus with dysplasia as the tissue at risk can be completely removed by ablation This premise has been tested in the Barretts dysplasia population in photoablative trials using PDT for patients with HGD where PDT imparted a 50 reduction in risk over controls for the development of adenocarcinoma Overholt BF Panjehpour M Haydek JM Photodynamic therapy for Barretts esophagus follow-up Gastrointest Endosc 19994911-7 The AIM Dysplasia Trial primary endpoints are removal of all dysplasia and IM rather than detection of a difference in progression to adenocarcinoma or higher grades of dysplasia
Patients who have a diagnosis of Barretts esophagus typically undergo surveillance endoscopy every 1-3 years with multiple biopsy specimens obtained to facilitate early detection of progression of IM to dysplasia more severe precancerous changes and adenocarcinoma Sampliner RE Updated guidelines for the diagnosis surveillance and therapy of Barretts esophagus Am J Gastro 2002971888-1895 Progression of IM to low-grade dysplasia LGD indicates that cells exhibit more cancer-like architecture thus warranting an accelerated surveillance endoscopy and biopsy program every 6 months rather than every 1-3 years as indicated for non-dysplastic IM Progression to high-grade dysplasia HGD indicates that the cells are even more cancer-like thus warranting an even higher frequency surveillance endoscopy and biopsy program every 3 months Many HGD patients may undergo photodynamic therapy PDT or surgical esophagectomy rather than remain in a frequent surveillance program This more aggressive therapy is warranted because of the high rate of progression of HGD to adenocarcinoma
Esophageal adenocarcinoma most commonly occurs after an insidious progression from IM to LGD to HGD Therefore surveillance is increased upon diagnosis of worsening grades of dysplasia The incidence of esophageal adenocarcinoma is rapidly increasing as middle-aged and elderly demographic sub-groups expand Peters JH Hagen JA DeMeester SR Barretts Esophagus J Gastrointest Surg 2004811-17 In 2004 the American Cancer Society reported that there were 14250 new cases of esophageal cancer and 13300 deaths attributable to esophageal cancer wwwcancerorg The US National Cancer Institute Surveillance Epidemiology and End Results Program reported that the increasing incidence of esophageal adenocarcinoma was greater than for any other cancer in the United States wwwcancergov
Elimination of the diseased epithelium containing IM with dysplasia is an intuitively favorable step for patients with this diagnosis In other disease states such as colon polyps or premalignant skin lesions removal of the premalignant tissue results in a reduction in the risk of ultimately developing cancer This is a logical conclusion when considering the premalignant lesion of Barretts esophagus particularly Barretts esophagus with dysplasia as the tissue at risk can be completely removed by ablation This premise has been tested in the Barretts dysplasia population in photoablative trials using PDT for patients with HGD where PDT imparted a 50 reduction in risk over controls for the development of adenocarcinoma Overholt BF Panjehpour M Haydek JM Photodynamic therapy for Barretts esophagus follow-up Gastrointest Endosc 19994911-7 The AIM Dysplasia Trial primary endpoints are removal of all dysplasia and IM rather than detection of a difference in progression to adenocarcinoma or higher grades of dysplasia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None