Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers
A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Cryo-Ablator System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories to destroy tissue during surgical procedures by applying extreme cold.
Patients will prepare for esophagogastroduodenoscopy (EGD) in the standard fashion using an overnight fast with only clear liquids and required medications allowed up to 2 hours before the procedure. The EGD will be performed using a therapeutic Olympus endoscope. The cryocatheter is passed into the therapeutic channel of the endoscope. Liquid nitrogen is sprayed through the cryocatheter for a duration of 10 seconds as measured by the device integrated timer. This process will be repeated four times in piecemeal fashion such that for any given area treated it will be maintained in a frozen state for a total of 40 seconds. Following circumferential treatment, the process will be repeated again applying the spray to the same section of mucosa for a duration of 20 seconds. Patients will be contacted the following day to assess for any immediate complications.
Patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury, until complete ablation of the Barrett's mucosa has been achieved. Follow up period of five years to monitor healing and progression.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44195
- The Cleveland Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Group 1:
- Co-morbid conditions such as severe heart, lung, kidney or liver disease.
- Refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy.
Group 2:
- Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with lesions extending beyond the mucosa but limited to the esophageal wall
Exclusion Criteria:
- Age less than 18 years
- Co-morbid illness expected to cause death within 6 months
- Pregnancy
- Refusal or inability to give consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Barrett's Esophagus with intramucosal carcinoma (IMCA)
|
Liquid nitrogen spray with a cryospray catheter through an upper endoscope that enables the direct visualization of mucosal freeze (cryoburn) of the mucosa treated which avoids the need for direct tissue contact.
Frozen state is defined as mucosa appearing white.
Cryofreeze is preformed in cycles of 10 second sprays with a minimal thaw of 60 seconds each spray.
This cycle is repeated 4 times in each area of treatment.
|
|
Experimental: Barrett's Esophagus with High Grade Dysplasia (HGD)
|
Liquid nitrogen spray with a cryospray catheter through an upper endoscope that enables the direct visualization of mucosal freeze (cryoburn) of the mucosa treated which avoids the need for direct tissue contact.
Frozen state is defined as mucosa appearing white.
Cryofreeze is preformed in cycles of 10 second sprays with a minimal thaw of 60 seconds each spray.
This cycle is repeated 4 times in each area of treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.
Time Frame: at 12 months from start of treatment
|
Determined by the end of protocol biopsies: incremental (absence of HGD and IMCA in all specimens); partial (residual IMCA with absence of any dysplasia); complete (absence of any intestinal metaplasia or dysplasia)
|
at 12 months from start of treatment
|
|
Number of patients that experience toxicity with cryotherapy
Time Frame: at 12 months from start of therapy
|
Toxicity is defined as death or esophageal perforation
|
at 12 months from start of therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the degree of tumor ablation of inoperable early esophageal cancer
Time Frame: at 12 months from start of therapy
|
Number of patient with each response determined by the end of protocol biopsies: incremental (absence of HGD and IMCA in all specimens); partial (residual IMCA with absence of any dysplasia); complete (absence of any intestinal metaplasia or dysplasia); no response
|
at 12 months from start of therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John A. Dumot, D.O., The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASE5205
- Cleveland Clinic IRB 8270 (Other Identifier: Cleveland Clinic IRB)
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