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

GERD Clinical Trial

Official title:

Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00321958
• Other study ID #: H-27406
• Secondary ID: CCT Number = 351
• Status: Terminated
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. It is hypothesized that this treatment will remove the abnormal lining of the esophagus and allow the normal esophageal lining to return.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Deglutition Disorders
• Esophageal Neoplasms
• GERD
• Neoplasm
• Neoplasms

Intervention

Device:
• CSA System (CryoSpray AblationTM System)
10 second spray times
• CryoSpray Ablation
10 second spray times

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine and Greenebaum Cancer Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	CSA Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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.

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. — View Citation

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. — View Citation

Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review. — View Citation

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. 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.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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Study end
Secondary	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	Study midpoint and end
Secondary	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	Study end
Secondary	Rate of adverse events	Rate of adverse events	Throughout study
Secondary	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	Throughout study
Secondary	Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia	Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia	Study end
Secondary	Number of treatment sessions needed to ablate dysplasia	Number of treatment sessions needed to ablate dysplasia	Throughout study