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临床试验/NCT03039608
NCT03039608已完成不适用

Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm:a Randomized Controlled Trial

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年2月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
the stricture rate

研究概览

简要总结

The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently these years especially in Asian countries. However, besides of perforation and bleeding, another complication postoperative esophageal stricture is frequently observed after the removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative stricture substantially decreases the patient's quality of life, requiring further therapy. Although the exact incidence is unknown, esophageal stricture is supposed to be related to the extent of the circumference being resected. In previous study by Ono et al,it is reported that 90% of patients with lesions of circumferential extension of more than three-fourths experienced postoperative stricture after esophageal ESD. There were some reported studies exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled that just oral prednisolone oral is effective option for the prevention of post-ESD stricture. However, most of the reported studies were non RCTs with small sample. In the primary study, the investigators search a new method of combination of both oral and local injection to prevent esophageal stricture,as a result,stricture at 8 weeks after ESD was found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the corticosteroid group. Unfortunately,the study was also retrospective. So, the investigators plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic effects of combination of local steroid injection with oral steroid administration for esophageal stenoses complicating extensive ESD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who has undergone esophageal ESD
  • Histologically confirmed early squamous cell carcinoma or high grade intraepithelial neoplasia of the esophagus
  • ESD resulted in a mucosal defect involving more than two-thirds of the esophageal circumference.

排除标准

  • Severe circulatory or respiratory disease,severe renal impairment
  • Women in pregnancy and lactation
  • Patients with steroid contraindications
  • Patients refuse to join in this study

研究组 & 干预措施

combination group

Experimental

combination of local steroid injection(triamcinolone )with oral steroid administration(prednisone)

干预措施: combination of local steroid injection(triamcinolone )with oral steroid administration(prednisone) (Drug)

control group

Active Comparator

oral steroid administration(prednisone)

干预措施: oral steroid administration(prednisone) (Drug)

结局指标

主要结局

the stricture rate

时间窗: 12weeks

the incidence of esophageal rate after ESD

the time when stricture occurs

时间窗: 12weeks

次要结局

  • the frequency of complications(12 months)
  • the frequency of dilatation sessions required(12 months)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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