Quality of Life Assessment of Cryotherapy in Esophageal or Gastroesophageal Cancer
NCT ID: NCT03285035
Last Updated: 2019-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2017-07-13
2021-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Non-operable esophageal cancer
Cryotherapy treatment
Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.
Upper endoscopy with cryotherapy using liquid nitrogen.
Interventions
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Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.
Upper endoscopy with cryotherapy using liquid nitrogen.
Eligibility Criteria
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Inclusion Criteria
* Dysphagia score of 1, 2, 3 or 4.
* Age ≥18 years old
* American Society of Anesthesiologists (ASA) Physical Status Classification ≤ 4
* Deemed not a candidate for esophageal cancer surgical resection
* Female subjects must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e., total abstinence, birth control pills, an intrauterine device (IUD), diaphragm, progesterone injections or implants, or condoms plus a spermicide) for the duration of the study
Exclusion Criteria
* Patient who received radiation treatment in the prior 8 weeks
* Known brain metastases causing cranial nerve deficits which can cause dysphagia
* Inability to undergo an esophagogastroduodenoscopy (EGD)
* Pregnant or nursing
* Surgery or anatomy where capacity of stomach is reduced making cryotherapy contraindicated
* Patients with tracheoesophageal fistula
18 Years
99 Years
ALL
No
Sponsors
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Western Regional Medical Center
OTHER
Responsible Party
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Principal Investigators
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Toufic Kachaamy, MD
Role: PRINCIPAL_INVESTIGATOR
Western Regional Medical Center
Locations
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Western Regional Medical Center, Inc.
Goodyear, Arizona, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Kachaamy T, Sharma N, Shah T, Mohapatra S, Pollard K, Zelt C, Jewett E, Garcia R, Munsey R, Gupta S, Rojas-DeLeon M, Gupta D, Kaul V, Pannala R, Vashi P. A prospective multicenter study to evaluate the impact of cryotherapy on dysphagia and quality of life in patients with inoperable esophageal cancer. Endoscopy. 2023 Oct;55(10):889-897. doi: 10.1055/a-2105-2177. Epub 2023 Jun 2.
Other Identifiers
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WG2015029
Identifier Type: -
Identifier Source: org_study_id
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