TerminatedNCT00321958Updated Feb 8, 2022

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

An observational study in Barrett Esophagus, Esophageal Neoplasms and Deglutition Disorders, sponsored by University of Maryland, Baltimore. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by University of Maryland, Baltimore · Observational

Why this study was terminated

The sponsor determined that adequate data had been acquired.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 23
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Barrett Esophagus
Esophageal Neoplasms
Deglutition Disorders
GERD
Neoplasm

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Keywords

Barrett Esophagus
Esophageal Neoplasm
Deglutition disorders
Cryotherapy
Cryosurgery
GERD
Neoplasm
Esophagus
Endoscopy, Digestive System

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 23 is below the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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

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

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 23 participants (actual)
Patient registry: No

Interventions

DeviceCSA System (CryoSpray AblationTM System)
10 second spray times
Also known as: CSA, Cryo
DeviceCryoSpray Ablation
10 second spray times
Also known as: CSA, cryo

What researchers measure

Primary outcomes

HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma
HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma
Time frame: Study end

Secondary outcomes

HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma
HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma
Time frame: Study midpoint and end
Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma
Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma
Time frame: Study end
Rate of adverse events
Rate of adverse events
Time frame: Throughout study
Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence
Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence
Time frame: Throughout study
Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia
Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia
Time frame: Study end
Number of treatment sessions needed to ablate dysplasia
Number of treatment sessions needed to ablate dysplasia
Time frame: Throughout study

Study locations

1 site

University of Maryland School of Medicine and Greenebaum Cancer Center
Baltimore, Maryland 21201-1505, United States

References and documents

Publications

Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8. doi: 10.1016/j.gie.2005.05.008. PubMed 16301023 ↗
Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8. PubMed 14629105 ↗
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 CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92. doi: 10.1016/s0016-5107(99)70352-4. PubMed 10385730 ↗
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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00321958
Lead sponsor: University of Maryland, Baltimore
Collaborators: CSA Medical, Inc.
Responsible party: Bruce Greenwald (PI, University of Maryland, Baltimore) — Principal investigator
First posted: May 4, 2006
Start date: Apr 2006
Primary completion: May 2007
Completion: May 2007
Last update: Feb 8, 2022

Study contacts

Bruce D Greenwald, M.D.

principal investigator · University of Maryland

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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