Using oral prednisolone to prevent esophageal stricture after RFA treatment for esophageal neoplasia
Administration of Oral Prednisolone to Prevent Esophageal Stricture After Balloon-type Radiofrequency Ablation for Long-segment Esophageal Neoplasia
This study is testing if taking oral prednisolone can help prevent esophageal strictures in people who have had RFA treatment for esophageal cancer.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | E-DA Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Kaohsiung City) |
| Trial ID | NCT05768282 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of oral prednisolone to prevent esophageal stricture following endoscopic radiofrequency ablation (RFA) for long-segment esophageal squamous cell neoplasia (ESCN). RFA is an effective treatment for early ESCN, but post-procedure stricture remains a significant complication. The trial will administer oral prednisolone at a dosage of 30mg per day for 28 days to assess its efficacy and safety in reducing the incidence of stricture. The study aims to improve patient outcomes and quality of life by minimizing the need for additional interventions like balloon dilation.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed squamous intraepithelial neoplasia without stromal invasion and no lymph node metastasis.
Not a fit: Patients with a history of endoscopic resection, radiation therapy, or esophagectomy for esophageal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of esophageal strictures, improving recovery and quality of life for patients undergoing RFA.
How similar studies have performed: Previous studies have shown the efficacy of RFA in treating early ESCNs, but the use of oral prednisolone for preventing post-RFA stricture is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histology from endoscopic biopsies showed squamous intraepithelial neoplasia without stromal invasion; * No lymph node metastasis on endoscopic ultrasound or computed tomography; * Magnifying endoscopy showed the intraepithelial papillary capillary loop as type B1 pattern, according to the classification of the microvascular architecture of superficial esophageal carcinoma. Exclusion Criteria: * A prior history of endoscopic resection, radiation therapy or esophagectomy for esophageal cancer; * A stricture that prevented the passage of a therapeutic endoscope; * Uncontrolled coagulopathy; * Poorly controlled diabetes mellitus.
Where this trial is running
Kaohsiung City
- EDA Hospital — Kaohsiung City, Taiwan (Recruiting)
Study contacts
- Study coordinator: Wen-Lun Wang, Ph.D
- Email: warrengodr@gmail.com
- Phone: +886918464373
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.