Ablation of Intestinal Metaplasia Containing Dysplasia
Barrett Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT00282672 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ablation System plus anti-secretory medication (Device); Sham procedure plus anti-secretory medication (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic - MITG
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The % of Patients With Complete Eradication of Intestinal Metaplasia (IM) at 12 Month |
85; 81.5 | — |
| PRIMARY The % of Patients With Complete Eradication of Dysplasia at 12 Month |
95; 89.5 | — |
| PRIMARY The % of Patients With Complete Histological Clearance of Intestinal Metaplasia at 24 Months. |
100; 97.4; 93.3; 88.9 | — |
| PRIMARY 5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Years |
85.3; 96.8 | — |
| PRIMARY Durability of Eradication With no Additional Treatments |
75 | — |
| PRIMARY 5 Year Extension: % of All Patients Enrolled in the Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Years |
100; 96.8 | — |
| SECONDARY The % of Patients With Complete Histological Clearance of IM at 12 Months, Comparing Treatment Versus Sham Control Groups Within a Specific Dysplasia Subgroup |
85; 72.2; 81.5; 80 | — |
| SECONDARY Within the HGD Subgroup, the % of Patients With Complete Histological Clearance of HGD (CR-D) at 12 Months, Comparing Treatment Versus Sham Control Groups. |
89.4; 86.6 | — |
| SECONDARY Histological Clearance of IM (% Biopsies) |
85; 72.2; 81.5; 80 | — |
| SECONDARY Progression of Dysplasia (i.e., HGD to Adenocarcinoma, or LGD to HGD or Adenocarcinoma) |
5; 1; 1 | — |
| SECONDARY Subject Discomfort : Chest Pain Score on Day 1 |
0; 26; 0; 22 | — |
| SECONDARY Quality of Life Questionnaire (Baseline v. 12 and 24 Mos) |
— | — |
| SECONDARY Adverse Event Incidence |
7; 32; 17; 34 | — |
| SECONDARY For 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body Since Primary RFA (0-5 Years) |
2.7 | — |
| SECONDARY 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension and Available for Analysis at 5 Years Demonstrating Any Adenocarcinoma in Any Biopsy Obtained From the Esophageal Body After 2 Years and Inclusive of the 5 Year Visit |
— | — |
| SECONDARY 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 5 Year |
85.4 | — |
| SECONDARY 5 Year Extension:Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 5 Year |
100 | — |
| SECONDARY 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 4 Year |
79.1 | — |
| SECONDARY 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-IM at 3 Year |
92.9 | — |
| SECONDARY 5 Year Extension: Proportion (%) of All Patients Enrolled in This Extension Protocol and Available for Analysis Demonstrating CR-D at 4 Year |
93 | — |
| SECONDARY 5 Year Extension: Serious Adverse Event Incidence |
1; 3 | — |
| SECONDARY 5 Year Extension: All Cause Mortality of the Group From 2 to 5 Years. |
— | — |
Summary
Eligibility Criteria
Inclusion Criteria:1.Subject is 18-80 years of age, inclusive. 2.Subject has documented diagnosis of IM, maximum endoscopic length of 8 cm (as measured endoscopically from the TGF to the most proximal extent of the IM; i.e. TGF-TIM containing dysplasia as follows:
- For LGD: i.LGD documented on biopsy within previous 12 months from enrollment while subject on PPI therapy.
ii.Histology slides reviewed at central pathology service for trial confirm LGD on first confirmatory central pathology review or, if necessary, confirm LGD on a tie-breaker review by a second pathologist.
- For HGD: i.Regular, non-nodular, non-ulcerated mucosa. ii.HGD documented on biopsy within previous 6 months from enrollment. iii.Histology slides reviewed at central pathology service for Trial confirm HGD on first confirmatory review or, if necessary, confirm HGD on a tie-breaker review by a second pathologist.
iv.Baseline EUS within previous 12 months; 1.Catheter-based EUS excludes suspicious thickened Barrett's areas or, if suspicious areas found, prompts stacked biopsies of thickened area, the results of which do not render subject ineligible for enrollment.
3.For subjects with EMR history,the documented diagnosis of IM with dysplasia meets criterion #2 from biopsies collected either after the EMR procedure or during the EMR procedure but not from the EMR site.
4.Subject able to take oral proton pump inhibitor medication. 5.Subject able to discontinue aspirin and/or non-steroidal anti-inflammatory medications 7 days before and after all ablation procedures.
6.For female subjects of childbearing potential, a negative pregnancy test within 2 weeks of randomization.
7.Subject eligible for treatment and follow-up endoscopy and biopsy as required by the Protocol.
8.Subject willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation.
Exclusion Criteria:1.The subject is pregnant or planning a pregnancy during the study period.
2.Esophageal stricture preventing passage of endoscope or catheter. 3.Active esophagitis described as erosions or ulcerations encompassing more than 10% of distal esophagus.
4.Any history of malignancy of the esophagus. 5.Prior radiation therapy to the esophagus,except head and neck region radiation therapy.
6.Any previous ablative therapy within the esophagus (PDT, MPEC, APC, laser treatment, other).
7.History of EMR that meets any of the following criteria:a.EMR performed less than 8 weeks prior to the randomization endoscopy encounter
b.EMR performed in a wide field manner (encompassing more than 90 degrees of any area of the esophagus.
8.Any previous esophageal surgery, including except fundoplication without complications (i.e. no slippage, dysphagia, etc).
9.Evidence of esophageal varices during treatment endoscopy. 10.Report of uncontrolled coagulopathy with international normalized ratio (INR) > 1.3 or platelet count <75,000 platelets per µL 11.Subject has a life-expectancy of less than two years due to an underlying medical condition.
12.Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
13.Subject has an implantable pacing device (examples; AICD, neurostimulator, cardiac pacemaker)and has not received clearance for enrollment in this study by specialist responsible for the pacing device.
14.The subject is currently enrolled in an investigational drug or device trial that clinically interferes with the AIM Dysplasia Trial endpoints.
15.Subject suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol.
For the 5 year extension, patient must have:1. Enrolled in the B-204 protocol. 2. Completed 1 year follow-up. 3. Completed 2 year follow-up.
Data sourced from ClinicalTrials.gov (NCT00282672). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.