A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers - Full Text View

Sponsored by:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00650988

Purpose

This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

Condition	Intervention	Phase
Barretts Esophagus Esophageal Cancer	Procedure: Cryospray Ablation	Phase IV

MedlinePlus related topics: Cancer Endoscopy Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

Evaluate the efficacy and safety of esophageal endoscopic cryospray ablation. [ Time Frame: Safety is evaluated with each treatment. Efficacy result evaulation assessed at the 20 pt. milestone and after 37 patients. Treatment time frame: baseline and every 6 weeks. Surveillance phase biopsies at :3 ,6,9,12,18.24 months. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the degree of tumor ablation of inoperable esophageal cancer(T1sm or T2N0) [ Time Frame: Visual assessment each visit. Quick look biopsies may be done. Treatment time frame: baseline and every 6 weeks. Surveillance phase: Biopsies at 3,6,9,12,18,24 months. ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	September 2005
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Liquid nitrogen spray with a cryospray catheter through an upper endoscope that enables the direct visualization of mucosal freeze (cryoburn) of the mucosa treated which avoids the need for direct tissue contact. Frozen state is defined as mucosa appearing white. Cryofreeze is preformed in cycles of 10 second sprays with a minimal thaw of 60 seconds each spray. This cycle is repeated 4 times in each area of treatment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Group 1:

Co-morbid conditions such as severe heart, lung, kidney or liver disease.
Refusal of surgical intervention after a thorough discussion of the highly experimental nature of cryotherapy.

Group 2:

Patients with inoperable esophageal cancer (adenocarcinoma oe squamous cell CA) with lesions extending beyond the mucosa but limited to the esophageal wall (T1sm or T2N0)

Exclusion Criteria:

Age less than 18 years
Co-morbid illness expected to cause death within 6 months
Pregnancy
Refusal or inability to give consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650988

Locations

United States, Ohio
The Cleveland Clinic
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

Investigators

Principal Investigator:

John A. Dumot, D.O.

Cleveland Clinic

More Information

No publications provided

Responsible Party:	The Cleveland Clinic ( John A. Dumot D.O. , Vice Chairman of Clinical Practice )
Study ID Numbers:	IRB 8270, Cleveland Clinic IRB 8270
Study First Received:	March 30, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00650988 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The Cleveland Clinic:

Barrett's Esophagus
Cryospray ablation
High Grade Dysplasia
Early Esophageal Cancers

Esophageal Neoplasms
Esophageal Intramucosal Cancer (IMCA)
Esophageal Cancer limited to esophageal wall
Barretts esophagus High Grade Dysplasia (HGD)

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Digestive System Abnormalities
Digestive System Diseases
Esophageal Disorder

Barrett Syndrome
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Digestive System Abnormalities
Gastrointestinal Diseases

Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009