Esophageal Neoplasms Clinical Trial
Official title:
Administration of Oral Prednisolone to Prevent Esophageal Stricture After Balloon-type Radiofrequency Ablation for Long-segment Esophageal Neoplasia
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | EDA Hospital | Kaohsiung City |
Lead Sponsor | Collaborator |
---|---|
E-DA Hospital |
Taiwan,
Ono 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. — View Citation
Wang 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. — View Citation
Wang 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. Therap Adv Gastroenterol. 2016 May;9(3):257-64. doi: 10.1177/1756283X16633051. Epub 2016 Feb 25. — View Citation
Yamaguchi 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients with esophageal stenosis after RFA | 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. | at 1 month after the RFA procedure | |
Secondary | The number of endoscopic balloon dilatation sessions required | f the esophageal stenosis was confirmed by endoscopy, balloon dilation will be done to resolve the symptoms | at 1 month after the RFA procedure | |
Secondary | The adverse events rate | After oral prednisolone, the adverse events will be recorded. | up to 1 year |
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