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CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation


N/A
18 Years
N/A
Open (Enrolling)
Both
Barrett's Esophagus With Persistent Dysplasia or, Early Esophageal Adenocarcinoma After Radio Frequency Ablation

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Trial Information

CryoSpray Ablation for Barrett's Esophagus After Treatment Failure With Serial RadioFrequency Ablation


Inclusion Criteria:



- Age > 18 years old

- Able to provide informed consent

- Patients with unifocal or multifocal BE with HGD or IMCA who have failed at
least 2 serial RFA therapy.

- Patients who refused esophagectomy or deemed inoperable or whose BE dysplasia is not
amenable to endoscopic mucosal resection (EMR) treatment alone due to: (1) extensive
multifocal lesions (2) severe coagulopathy or any medical condition deemed high risk
for EMR (3) patient refuses EMR

- Patients with a nodular BE lesions may undergo clinically-indicated EMR and still be
eligible for enrollment as long as they have BE-HGD lesion/s that are still
candidate for ablative treatment

Exclusion Criteria:

- Age younger than 18 years old

- Life expectancy less than 12 months

- Pregnancy

- Presence of esophageal varices

- Esophageal stricture precluding passage of an endoscope and suction tubing

- Any procedure that has impeded normal gastric emptying or limited gastric volume
distention, including but not limited to gastric bypass, stomach stapling,
gastrojejunostomy or any disease state has significantly reduced the elasticity in
the GI tract (e.g. Marfan's syndrome, Scleroderma or any Connective Tissue Disease)

- Esophageal cancer (T2 and above)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Response

Outcome Description:

To assess efficacy of achieving elimination of dysplasia in patients with RFA-refractory BE with HGD or IMCA

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Kenneth K Wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

12-006030

NCT ID:

NCT01882478

Start Date:

June 2013

Completion Date:

June 2018

Related Keywords:

  • Barrett's Esophagus With Persistent Dysplasia or
  • Early Esophageal Adenocarcinoma After Radio Frequency Ablation
  • Barrett's esophagus
  • Early esophageal adenocarcinoma
  • Radio Frequency Ablation
  • Cryotherapy
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus
  • Esophageal Diseases

Name

Location

Mayo ClinicRochester, Minnesota  55905