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Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Barrett Esophagus, Esophageal Neoplasms, Deglutition Disorders, GERD, Neoplasm

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Trial Information

Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

HGD or inoperable intramucosal or submucosal carcinoma ans severe squamous dysplasia: measure of reduction in size of HGD or carcinoma

Outcome Time Frame:

Study end

Safety Issue:

No

Principal Investigator

Bruce D Greenwald, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland

Authority:

United States: Institutional Review Board

Study ID:

H-27406

NCT ID:

NCT00321958

Start Date:

April 2006

Completion Date:

May 2007

Related Keywords:

  • Barrett Esophagus
  • Esophageal Neoplasms
  • Deglutition Disorders
  • GERD
  • Neoplasm
  • Barrett Esophagus
  • Esophageal Neoplasm
  • Deglutition disorders
  • Cryotherapy
  • Cryosurgery
  • GERD
  • Neoplasm
  • Esophagus
  • Endoscopy, Digestive System
  • Barrett Esophagus
  • Neoplasms
  • Deglutition Disorders
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Gastroesophageal Reflux

Name

Location

University of Maryland School of Medicine and Greenebaum Cancer CenterBaltimore, Maryland  21201-1505