Prevention of post-ESD esophageal stricture by fluticasone inhaler administration: a single-arm, pilot study
- Conditions
- Neoplasms
- Registration Number
- KCT0008058
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Among patients who underwent ESD for esophageal lesions, patients who met the following criteria were selected:
- Patients with superficial esophageal cancer whose depth of invasion was confined to the mucosal layer (cT1a)
- Patients with no lymph node or distant metastases in chest/abdominal CT scan and clinical findings
- Patients whose post-ESD ulcer is expected to occupy more than 3/4 of the esophageal circumference.
- Adult patients between the ages of 19 and 80
- Patients with no history of adverse drug reactions to steroids.
- Patients with voluntarily decided to participate after hearing the explanation of the research process and signed the informed consent form.
Among patients who undergo ESD for esophageal lesions, patients who meet the following criteria are excluded from the study:
- Patients who did not consent to participate in the study.
- Patients with superficial esophageal cancer suspected of having invasion deeper than submucosa (cT1b or higher)
- In case of previous chemotherapy and radiation therapy in the esophagus
- Patients with infectious esophageal disease at the time of the procedure.
- Patients with a history of adverse events to steroid
- Patients with a history of underlying asthma, chronic obstructive pulmonary disease (COPD) or bronchiectasis
- Patients taking beta-blockers for diseases such as hypertension or arrhythmias
- Patients who cannot take steroid due to such as HIV infection, active tuberculosis, pregnancy, etc.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence of post-ESD esophageal stricture
- Secondary Outcome Measures
Name Time Method Compliance with steroid administration;Rate and number of additional procedures due to esophageal stricture;Adverse event due to steroid administration