Diagnostic and Therapeutic Efficacy and Safety of Single- and Double-balloon Enteroscopy in Pediatric Patients: An Inverse Probability of Treatment-weighted Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- diagnostic yield
研究概览
简要总结
The aim of our study was to compare the utility and safety of SBE and DBE in pediatric patients.
详细描述
The benefit of balloon-assisted enteroscopy (BAE) had been recently documented in pediatric patients, but no study has compared the use of single-balloon enteroscopy (SBE) and double-balloon enteroscopy (DBE) in pediatric patients to date. The aim of our study was to compare the utility and safety of SBE and DBE in pediatric patients. This retrospective study enrolled patients younger than 18 years between January 2015 and May 2024. Inverse probability of treatment-weighted (IPTW) adjustment was used to address the imbalance in variables. The outcomes included diagnostic yield, positive rate, complete enteroscopy, therapeutic yield, procedure times and complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study retrospectively collected clinical data and endoscopic information of pediatric patients (≤18 years) with suspected small bowel disease who underwent BAE consecutively at a tertiary medical center (Qilu Hospital of Shandong University, Jinan, China) from January 2015 to May 2024.
排除标准
- •(1) refusal for consent; (2) contraindication for deep sedation; (3) patients with incomplete clinical data and endoscopic information; (4) oral enteroscopy cannot pass the pylorus, and anal enteroscopy cannot pass the ileocecal valve.
研究组 & 干预措施
SBE group
干预措施: single-bollon enteroscopy (Device)
DBE group
干预措施: double-bollon enteroscopy (Device)
结局指标
主要结局
diagnostic yield
时间窗: From Baseline to the finish of enteroscopy
Diagnostic yield was defined as the percentage of procedures with a disease-specific definitive endoscopic diagnosis.
次要结局
- Positive rate(from baseline to the finish of enterscopy)
- Complete enteroscopy(start to the finish of the enteroscopy)
- Therapeutic yield(frome baselin to finish of the enteroscopy)
- procedure time(from start to finish of the enteroscopy)
- adverse events(From first day until 30 days)
研究者
Xiuli Zuo
Director of the Qilu Hospital Gastroenterology Department
Qilu Hospital of Shandong University