NCT01572987

Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus

Endoscopic Resection or Ablation for Patients With Dysplasia or Intramucosal Cancer in Barrett's Esophagus

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Midwest Biomedical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will evaluate a patient population with Barrett's esophagus(BE) containing high grade dysplasia or intramucosal cancer and compare the effects of endoscopically-guided radiofrequency ablation system(RFA) and endoscopically-guided stepwise endoscopic mucosal resection(S-EMR).

Detailed description

This is a multi-center prospective, randomized controlled trial conducted at 4 centers. The patients with high grade dysplasia(HGD) and/or esophageal cancer(EC) who meet the study criteria will be enrolled, undergo a baseline diagnostic EMR and then be randomized in a 1:1 ratio to undergo treatment by either S-EMR or radiofrequency ablation(RFA). The initial staging EMR will not extend more than 50% of the esophageal circumference or more than 2 cm in longitudinal extent. Patients in the S-EMR group will undergo step-wise eradication of the BE segment using the Duette multi-band mucosectomy kit (Cook Medical, FDA approved) whereas those in the RFA group will undergo BE ablation using the endoscopically-guided HALO radiofrequency ablation system (Barrx Medical, FDA approved). Both treatment groups will undergo their respective treatment sessions every 2 months until either no Barrett's esophagus is seen or until a maximum of 4 treatment sessions. Once there is no visible Barrett's esophagus, patients will undergo surveillance biopsies (random 4 quadrant biopsies every 1 cm of the neo-squamous mucosa and random biopsies of the cardia) to evaluate for complete eradication of Barrett's esophagus. Regardless of whether there is visible Barrett's esophagus, all patients will undergo repeat endoscopy every 2 months for 1 year after enrollment. If no visible Barrett's esophagus is seen during the endoscopy, then surveillance biopsies to evaluate for dysplasia will be taken. Regardless of whether this is any visible Barrett's esophagus, all patients will undergo surveillance biopsies at 12 months after enrollment. The objective of this study is to compare the proportion of patients with complete eradication of Barrett's esophagus using S-EMR versus RFA at 12 months.

Conditions

• Barrett's Esophagus
• Esophageal Neoplasms

Interventions

Type	Name	Description
DEVICE	Radiofrequency Ablation(RFA) by HALO device.	RFA or Surveillance every 2 months for 1 year.
DEVICE	Endoscopic mucosal resection(EMR) by mucosectomy kit.	EMR or surveillance every 2 months.

Timeline

• Start date: 2011-09-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2012-04-06
• Last updated: 2017-05-30

Locations

3 sites across 1 country: United States