Barrett Esophagus, Deglutition Disorders, Esophageal Neoplasms, GERD, Neoplasm
Conditions
Keywords
Barrett Esophagus, Esophageal Neoplasm, Deglutition disorders, Cryotherapy, Cryosurgery, GERD, Neoplasm, Esophagus, Endoscopy, Digestive System
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 high-grade dysplasia and early esophageal cancer. It is hypothesized that this treatment will remove the abnormal lining of the esophagus and allow the normal esophageal lining to return.
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 techniques are attempted to avoid the high morbidity and mortality of esophagectomy or for use in patients who cannot undergo surgery. Current ablative techniques have achieved mucosal ablation with variable success but are associated with high cost, patient discomfort and/or significant complications. A novel device which sprays liquid nitrogen through an upper endoscope (cryotherapy) has been shown to be a safe and effective procedure to ablate the esophageal mucosa in swine and dog models and in pilot studies in humans. Successful reversal of BE, LGD, HGD and superficial adenocarcinoma and squamous cell carcinoma have been demonstrated when cryotherapy with this device is followed by healing of the esophageal lining in a low acid environment. This study is undertaken to demonstrate the efficacy and safety in the ablation of Barrett's esophagus with high-grade, neoplasia, and severe esophageal squamous dysplasia and to confirm preliminary results in humans.
Interventions
DEVICECSA System (CryoSpray AblationTM System)
10 second spray times
DEVICECryoSpray Ablation
10 second spray times
Sponsors
CSA Medical, Inc.
University of Maryland, Baltimore
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma | Study end | HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma | Study end | Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma |
| Rate of adverse events | Throughout study | Rate of adverse events |
| HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma | Study midpoint and end | HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma |
| Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia | Study end | Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia |
| Number of treatment sessions needed to ablate dysplasia | Throughout study | Number of treatment sessions needed to ablate dysplasia |
| Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence | Throughout study | Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence |
Countries
United States
Outcome results
None listed