Clinical trial NCT00650988: Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers
Official title: A Pilot Study of Cryotherapy for Barrett's Esophagus With High-Grade Dysplasia and Early Esophageal Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Barretts Esophagus
Esophageal Cancer
Keywords: 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)
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The Cryo-Ablator System is a cryosurgical unit with a liquid nitrogen cooled cryocatheter and accessories to destroy tissue during surgical procedures by applying extreme cold.

Patients will prepare for esophagogastroduodenoscopy (EGD) in the standard fashion using an overnight fast with only clear liquids and required medications allowed up to 2 hours before the procedure. The EGD will be performed using a therapeutic Olympus endoscope. The cryocatheter is passed into the therapeutic channel of the endoscope. Liquid nitrogen is sprayed through the cryocatheter for a duration of 10 seconds as measured by the device integrated timer. This process will be repeated four times in piecemeal fashion such that for any given area treated it will be maintained in a frozen state for a total of 40 seconds. Following circumferential treatment, the process will be repeated again applying the spray to the same section of mucosa for a duration of 20 seconds. Patients will be contacted the following day to assess for any immediate complications.

Patients will repeat treatment every 6 weeks if no evidence of esophageal mucosal injury, until complete ablation of the Barrett's mucosa has been achieved. Follow up period of five years to monitor healing and progression.

Eligibility 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of patients that achieved successful ablation of dysplasia and neoplasia Barrett's Esophagus.
timeFrame: at 12 months from start of treatment
measure: Number of patients that experience toxicity with cryotherapy
timeFrame: at 12 months from start of therapy
Secondary outcomes:
measure: Assess the degree of tumor ablation of inoperable early esophageal cancer
timeFrame: at 12 months from start of therapy
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: John A. Dumot, D.O.
role: PRINCIPAL_INVESTIGATOR
References: