JPRN-UMIN000015532已完成未知
Exploratory clinical study concerning the efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection of superficial esophageal neoplasms. - The efficacy of "steroid injection" and "shielding method with polyglycolic acid sheets and fibrin glue" for the prevention of postoperative stricture after esophageal endoscopic submucosal dissection.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
published doi:10.1038/ajg.2016.60 Between December 2014 and July 2015, 15 patients were enrolled. Each underwent per-protocol treatment with an ESD defect of over 3/4 the circumference of the esophagus. Four patients were excluded from analysis due to salvage esophagectomy. The remaining 11 patients (2 total circumferential, 9 semi-circumferential) were followed for 12 weeks. Postoperative stricture occurred in 18.2% (2/11), with a median of 0 sessions of EBD required. Postoperative stricture was successfully prevented in one case of total circumferential resection. Of the semi-circumferential cases, postoperative stricture occurred in 11.1% (1/9), with a median of 0 EBD sessions.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1) The patient has received endoscopic treatment of the upper GI tract within 30 days of entry. 2) The patient is to receive endoscopic treatment of either the stomach or duodenum in the same session. 3) The patient has plans of receiving endoscopic treatment of the upper GI tract within 12 weeks. 4) The patient has allergy to either Lugol staining, polyglycolic acid, steroids, PPIs. 5) Possibility of pregnancy 6) Neuropsychiatric symptoms which may impair comprehension of the study. 7) A history of either angina or cardiac infarction within 3 months 8) Uncontrolled hypertension 9) Others
研究者
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