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Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321958
Recruitment Status : Terminated (The sponsor determined that adequate data had been acquired.)
First Posted : May 4, 2006
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
CSA Medical, Inc.
Information provided by (Responsible Party):
Bruce Greenwald, University of Maryland, Baltimore

Study Description
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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.

Condition or disease Intervention/treatment
Barrett Esophagus Esophageal Neoplasms Deglutition Disorders GERD Neoplasm Device: CSA System (CryoSpray AblationTM System) Device: CryoSpray Ablation

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.

Study Design
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Study Type : Observational
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer
Study Start Date : April 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: CSA System (CryoSpray AblationTM System)
    10 second spray times
    Other Names:
    • CSA
    • Cryo
  • Device: CryoSpray Ablation
    10 second spray times
    Other Names:
    • CSA
    • cryo

Outcome Measures
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Primary Outcome Measures :
  1. HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma [ Time Frame: Study end ]
    HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma


Secondary Outcome Measures :
  1. HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma [ Time Frame: Study midpoint and end ]
    HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma

  2. Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma [ Time Frame: Study end ]
    Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma

  3. Rate of adverse events [ Time Frame: Throughout study ]
    Rate of adverse events

  4. Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence [ Time Frame: Throughout study ]
    Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence

  5. Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia [ Time Frame: Study end ]
    Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia

  6. Number of treatment sessions needed to ablate dysplasia [ Time Frame: Throughout study ]
    Number of treatment sessions needed to ablate dysplasia


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will have Barrett's esophagus and high grade dysplasia or intramucosal cancer, squamous dysplasia, or mucosal/submucosal cancer
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321958


Locations
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United States, Maryland
University of Maryland School of Medicine and Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1505
Sponsors and Collaborators
University of Maryland, Baltimore
CSA Medical, Inc.
Investigators
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Principal Investigator: Bruce D Greenwald, M.D. University of Maryland
More Information
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Publications:
Johnston, M.H. Endoscopic cryotherapy: A new ice age in gastroenterology? [Electronic version]. Medscape Gastroenterology 2:(4)2000.
Johnston, M.H., Eastone, J.A., & Horwhat, J.D. Reversal of Barrett's esophagus with cryotherapy [Abstract]. American Journal of Gastroenterology 98: (9,Suppl), A30,S11, 2003.
Johnston, M., Horwhat, J., Dubois, A., & Schoenfeld, P. Endoscopic cryotherapy in the swine esophagus: A follow-up study [Abstract]. Gastrointestinal Endoscopy 49: AB126, 1999.
Johnston, M.H., Horwhat, J.D., Haluska, O., & Moses, F.M. Depth of injury following endoscopic spray cryotherapy: EUS assisted evaluation of mucosal ablation and subsequent healing in the swine model [Abstract] [Electronic version]. Gastrointestinal Endoscopy 51: AB98,3462, 2000.
Johnston, M.H., Schoenfeld, P., Mysore, J., Kita, J.A., & Dubois, A. Endoscopic cryotherapy: A new technique for tissue ablation in the esophagus [Abstract]. American Journal of Gastroenterology 92: A44, 1997.
Eastone, J.A., Horwhat, D., Haluska, O., Mathews, J., & Johnston, M. Cryoablation of swine esophageal mucosa: A direct comparison to argon plasma coagulation (APC) and multipolar electrocoagulation (MPEC) [Abstract] [Electronic version]. Gastrointestinal Endoscopy 53: A3448, 2001.

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Responsible Party: Bruce Greenwald, PI, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT00321958    
Other Study ID Numbers: H-27406
CCT Number = 3511 ( Other Grant/Funding Number: UMB )
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: January 2022
Keywords provided by Bruce Greenwald, University of Maryland, Baltimore:
Barrett Esophagus
Esophageal Neoplasm
Deglutition disorders
Cryotherapy
Cryosurgery
 GERD
Neoplasm
Esophagus
Endoscopy, Digestive System
Additional relevant MeSH terms:
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Neoplasms
Esophageal Neoplasms
Barrett Esophagus
Deglutition Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Precancerous Conditions
Pharyngeal Diseases
Otorhinolaryngologic Diseases