Status:
TERMINATED
Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
CSA Medical, Inc.
Conditions:
Barrett Esophagus
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to confirm the effectiveness and safety of a new medical device which sprays liquid nitrogen through an upper endoscope (cryotherapy) to treat Barrett's esophagus with hig...
Detailed Description
Barrett's esophagus (BE) with high grade dysplasia (HGD) is a precursor of esophageal adenocarcinoma. Eliminating this condition may control the current rapid rise of adenocarcinoma. Ablative techniqu...
Eligibility Criteria
Inclusion
- High Grade-IMCancer:
- Diagnosis of Barrett's esophagus and high-grade dysplasia or intramucosal carcinoma
- Deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy
- CT scan of the chest and abdomen with oral and intravenous contrast (unless allergic), demonstrating no evidence of advanced esophageal cancer (extension into or through the wall or lymph node involvement)
- Endoscopic ultrasound evaluation demonstrating no evidence of metastatic lymph node involvement or extension of carcinoma beyond the mucosa
- Pathology review of esophageal biopsies by two independent reviewers, including at least one from the Department of Pathology at the University of Maryland, to confirm the diagnosis of Barrett's esophagus with HGD and/or IMCA
- Presentation and discussion at Thoracic Tumor Board
- Mucosal/submucosal cancer:
- Diagnosis of esophageal carcinoma
- Deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy
- CT scan of the chest and abdomen with oral and intravenous contrast (unless allergic), demonstrating no evidence of advanced esophageal cancer (extension through the wall or lymph node involvement)
- Endoscopic ultrasound evaluation demonstrating no evidence of metastatic lymph node involvement and primary lesion extending into submucosa or muscularis propria (T1smN0 or T2N0)
- Presentation and discussion at Thoracic Tumor Board
- Patients who have undergone previous ablation therapies are eligible for this study.
- Severe squamous dysplasia:
- Diagnosis of severe dysplasia within esophageal squamous mucosa
- Deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy
- CT scan of the chest and abdomen with oral and intravenous contrast (unless allergic), demonstrating no evidence of advanced esophageal cancer (extension into or through the wall or lymph node involvement)
- Endoscopic ultrasound evaluation demonstrating no evidence of metastatic lymph node involvement or extension of carcinoma beyond the mucosa
- Pathology review of esophageal biopsies by two independent reviewers, including at least one from the Department of Pathology at the University of Maryland, to confirm the diagnosis
- Presentation and discussion at Thoracic Tumor Board
Exclusion
- Age less than 18 years
- Co-morbid illness expected to cause death within 6 months
- Pregnancy
- Medically unfit or other contraindication to tolerate upper endoscopy
- Inability to tolerate therapy with a proton pump inhibitor (PPI)
- Refusal or inability to give consent
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00321958
Start Date
April 1 2006
End Date
May 1 2007
Last Update
February 8 2022
Active Locations (1)
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1
University of Maryland School of Medicine and Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1505