Clinical trial · Interventional
Oral Prednisolone to Prevent Esophageal Stricture After RFA for Long-segment Esophageal Neoplasia
Administration of Oral Prednisolone to Prevent Esophageal Stricture After Balloon-type Radiofrequency Ablation for Long-segment Esophageal Neoplasia
NCT05768282CI-TRIAL-00064758unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Endoscopic radiofrequency ablation (RFA) has shown good efficacy and safety in eradicating flat-type early esophageal squamous cell neoplasia (ESCN). However, post-RFA stricture is still a major concern, especially when treating long-segment early ESCNs. The aim of this study was to investigate the efficacy and safety of oral prednisolone to prevent post-RFA stricture.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophagus Stenosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oral prednisolone (30mg/day) for 28 days | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of oral prednisolone
- description
- Oral prednisolone start at a dose of 30 mg/day on the third day after RFA, and continue for 4 weeks.
- interventionNames
- Drug: Oral prednisolone (30mg/day) for 28 days
Primary outcomes (1)
- measure
- The proportion of patients with esophageal stenosis after RFA
- timeFrame
- at 1 month after the RFA procedure
- description
- Defined as the failure of a standard endoscope (9.8 mm in diameter) to pass through the stenosis.Then the outcome measures will be compared with a historical control, that just received endoscopic surveillance.
Secondary outcomes (2)
- measure
- The number of endoscopic balloon dilatation sessions required
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDOno S, Fujishiro M, Niimi K, Goto O, Kodashima S, Yamamichi N, Omata M. Predictors of postoperative stricture after esophageal endoscopic submucosal dissection for superficial squamous cell neoplasms. Endoscopy. 2009 Aug;41(8):661-5. doi: 10.1055/s-0029-1214867. Epub 2009 Jun 29. PMID 19565442
- BACKGROUNDYamaguchi N, Isomoto H, Nakayama T, Hayashi T, Nishiyama H, Ohnita K, Takeshima F, Shikuwa S, Kohno S, Nakao K. Usefulness of oral prednisolone in the treatment of esophageal stricture after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma. Gastrointest Endosc. 2011 Jun;73(6):1115-21. doi: 10.1016/j.gie.2011.02.005. Epub 2011 Apr 14. PMID 21492854
- BACKGROUNDWang WL, Chang IW, Chen CC, Chang CY, Tseng CH, Tai CM, Lin JT, Wang HP, Lee CT. Lessons from pathological analysis of recurrent early esophageal squamous cell neoplasia after complete endoscopic radiofrequency ablation. Endoscopy. 2018 Aug;50(8):743-750. doi: 10.1055/s-0044-101352. Epub 2018 Feb 15. PMID 29448289
- BACKGROUNDWang WL, Chang IW, Chen CC, Chang WL, Chu YY, Wu PH, Tai WC, Chen PY, Hsieh PH, Chung CS, Chang CY, Lin JT, Wang HP, Lee CT. Predictors for postoperative esophageal stricture after balloon-based radiofrequency ablation for early esophageal squamous neoplasia: a multicenter validation study. Ther Adv Gastroenterol. 2016 May;9(3):257-64. doi: 10.1177/1756283X16633051. Epub 2016 Feb 25. PMID 27134656
- DERIVEDWang WL, Tsai YN, Hsu MH, Lin JT, Wang HP, Lee CT. Administration of oral prednisolone to prevent esophageal stricture after balloon-type radiofrequency ablation for ultralong-segment esophageal neoplasia. Gastrointest Endosc. 2024 Aug;100(2):192-199. doi: 10.1016/j.gie.2024.03.030. Epub 2024 Apr 5. PMID 38583540