Biliary Stent For Management Of Esophageal Stricture In Children: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- incidence of recurrence of stenosis
研究概览
简要总结
All patients will subjected to the followings:
patients were selected by randomization method, full history taking, Complete physical examination, laboratory investigations (complete blood picture, liver and kidney functions, coagulation profile, tumor marker tests, serum electrolytes), patients were assessed radio-logically by abdominal x- ray , abdominal ultrasound, pelvic and abdominal CT.
For patients in EG, we began with assessment of the site & lenght of stricture . In this study, we used fully covered self expanded metallic biliary stent.
For patients in SG, we usually did gastrotomy feeding tube, excision and re-anastomosis, or did esophageal replacement surgery
详细描述
Technical design:
A- Site of the study: The investigators included all patients who were presented to General Surgery Department with Esophgeal Stricuture In Children at Zagazig University hospital between (December 2024 to December 2025).
B- Sample size:
c- Sample selection: Included patients were randomized at a 1:1 ratio to "Endoscopic Group, EG" or "Surgical Group , SG" via the drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before the start of the intervention.(simple random sample).
D- Subjects: Patients will be divided into 2 groups in accordance type of preoperative
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Esophageal Stricture In Children.
- •recurrent fistula.
- •failed conservative measures .
- •patient with good general condition (ASA I&II).
排除标准
- •bad general condition (ASAIII&IV&V).
- •respond to conservative measures.
研究组 & 干预措施
Endoscopic Group
endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent.
干预措施: endoscopic stenting of esophageal stricture by fully covered self expanding metallic stent (Procedure)
surgical group
resection and reconstruction of stenosed esophageal segemt
结局指标
主要结局
incidence of recurrence of stenosis
时间窗: within one week after the endoscopy
incidence of recurrence of stenosis
次要结局
- incidence of side effects of endoscopy(within one month after the endoscopy)