Prevention of post-ESD esophageal stricture by fluticasone inhaler administration: a single-arm, pilot study

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0008058

Enrollment

Registered

2022-12-30

Start date

2023-03-30

Completion date

Unknown

Last updated

2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : This is a pilot study with a single arm to assess if fluticasone steroid prevents post-ESD esophageal stricture. Flutiform inhaler (fluticasone propionate 250µg + formoterol fumarate 10µg) is a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
incidence of post-ESD esophageal stricture	—

Secondary

Measure	Time frame
Compliance with steroid administration;Rate and number of additional procedures due to esophageal stricture;Adverse event due to steroid administration	—

Countries

Korea, Republic of

Contacts

Public ContactYuri Kim

Asan Medical Center

arcoiris0209@gmail.com+82-2-3010-0854

Outcome results