AzTrials
AzTrials

Barrett EsophagusNCT00321958

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

An observational study of Barrett Esophagus and Esophageal Neoplasms, run by University of Maryland, Baltimore at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CSA System (CryoSpray AblationTM System) and CryoSpray Ablation
Type of treatment
Medical device
How many people
23 participants
Where
1 siteUnited States
Study dates
Apr 2006to May 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will have Barrett's esophagus and high grade dysplasia or intramucosal cancer, squamous dysplasia, or mucosal/submucosal cancer

Who may be able to join

  • 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
Show all 21Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Maryland School of Medicine and Greenebaum Cancer Center

    Baltimore, Maryland, 21201-1505

Other trials in United States

About this study

Official title: Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer

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.

Being tested
CSA System (CryoSpray AblationTM System), CryoSpray Ablation
Keywords
Barrett Esophagus, Esophageal Neoplasm, Deglutition disorders, Cryotherapy, Cryosurgery, GERD, Neoplasm, Esophagus, Endoscopy, Digestive System
Medical subject headings
Barrett Esophagus, Esophageal Neoplasms, Deglutition Disorders, Gastroesophageal Reflux, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CSA System (CryoSpray AblationTM System)Device

    Also called CSA, Cryo

    10 second spray times

  • CryoSpray AblationDevice

    Also called CSA, cryo

    10 second spray times

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Study end

Secondary outcomes (6)

  1. 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

    Measured: Study midpoint and end

  2. 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

    Measured: Study end

  3. Rate of adverse events

    Rate of adverse events

    Measured: Throughout study

  4. 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

    Measured: Throughout study

  5. Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia

    Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia

    Measured: Study end

  6. Number of treatment sessions needed to ablate dysplasia

    Number of treatment sessions needed to ablate dysplasia

    Measured: Throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionMay 2007
  4. Study completionMay 2007

Why it stopped: The sponsor determined that adequate data had been acquired.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00321958
Sponsor's protocol ID
H-27406
Other IDs
CCT Number = 3511
Status last verified
Jan 2022
First submitted
3 May 2006
Last updated
8 Feb 2022
Results posted
No
Data monitoring committee
Yes

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Barrett Esophagus and Esophageal Neoplasms, run by University of Maryland, Baltimore at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The sponsor determined that adequate data had been acquired.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma (time frame: Study end). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00321958, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in