Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers
Primary Purpose
Barretts Esophagus, Esophageal Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cryospray Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Barretts Esophagus focused on measuring Barrett's Esophagus, Cryospray ablation, High Grade Dysplasia, Early Esophageal Cancers, Esophageal Neoplasms, Esophageal Intramucosal Cancer (IMCA), Esophageal Cancer limited to esophageal wall, Barretts esophagus High Grade Dysplasia (HGD)
Eligibility Criteria
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
Sites / Locations
- The Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Barrett's Esophagus with intramucosal carcinoma (IMCA)
Barrett's Esophagus with High Grade Dysplasia (HGD)
Arm Description
Outcomes
Primary Outcome Measures
Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.
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)
Number of patients that experience toxicity with cryotherapy
Toxicity is defined as death or esophageal perforation
Secondary Outcome Measures
Assess the degree of tumor ablation of inoperable early esophageal cancer
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
Full Information
NCT ID
NCT00650988
First Posted
March 30, 2008
Last Updated
December 21, 2012
Sponsor
Case Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00650988
Brief Title
Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers
Official Title
A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barretts Esophagus, Esophageal Cancer
Keywords
Barrett's Esophagus, Cryospray ablation, High Grade Dysplasia, Early Esophageal Cancers, Esophageal Neoplasms, Esophageal Intramucosal Cancer (IMCA), Esophageal Cancer limited to esophageal wall, Barretts esophagus High Grade Dysplasia (HGD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Barrett's Esophagus with intramucosal carcinoma (IMCA)
Arm Type
Experimental
Arm Title
Barrett's Esophagus with High Grade Dysplasia (HGD)
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Cryospray Ablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.
Description
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)
Time Frame
at 12 months from start of treatment
Title
Number of patients that experience toxicity with cryotherapy
Description
Toxicity is defined as death or esophageal perforation
Time Frame
at 12 months from start of therapy
Secondary Outcome Measure Information:
Title
Assess the degree of tumor ablation of inoperable early esophageal cancer
Description
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
Time Frame
at 12 months from start of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John A. Dumot, D.O.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers
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