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

NCT00321958 | Terminated DMC

• 2 other identifiers: H-27406CCT Number = 3511
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (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

  Study end

Secondary Outcomes (6)

• HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma

  Study midpoint and end

• Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma

  Study end

• Rate of adverse events

  Throughout study

• Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence

  Throughout study

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

  Study end

Interventions

CSA System (CryoSpray AblationTM System) DEVICE

10 second spray times

Also known as: CSA, Cryo

CryoSpray Ablation DEVICE

10 second spray times

Also known as: CSA, cryo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• CSA Medical, Inc.: collaborator

Study Sites (1)

University of Maryland School of Medicine and Greenebaum Cancer Center

Baltimore, Maryland, 21201-1505, United States

Location

Related Publications (9)

• 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.

  PMID: 16301023 BACKGROUND

• 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.

  PMID: 14629105 BACKGROUND

• Johnston, M.H. Endoscopic cryotherapy: A new ice age in gastroenterology? [Electronic version]. Medscape Gastroenterology 2:(4)2000.

  BACKGROUND

• 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.

  BACKGROUND

• Johnston, M., Horwhat, J., Dubois, A., & Schoenfeld, P. Endoscopic cryotherapy in the swine esophagus: A follow-up study [Abstract]. Gastrointestinal Endoscopy 49: AB126, 1999.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10385730 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus; Esophageal Neoplasms; Deglutition Disorders; Gastroesophageal Reflux; Neoplasms

Interventions

Cryoelectron Microscopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Motility Disorders

Intervention Hierarchy (Ancestors)

Microscopy, Electron; Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Bruce D Greenwald, M.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 3, 2006
• First Posted: May 4, 2006
• Study Start: April 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 8, 2022

Record last verified: 2022-01

Locations

US (1)