Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis; a Prospective Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Endoscopic therapy success
研究概览
简要总结
Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health.
For benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines.
Since the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult.
Therefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic benign esophageal stenosis
- •medical indication for endoscopic therapy
- •written consent after detailed information
排除标准
- •non-benign esophageal stenosis
- •missing written consent
- •trans-oral endoscopic access is not possible
- •medical contraindication for endoscopic dilatation therapy
- •age <18 years
研究组 & 干预措施
Conventional Measurement
Esophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only
干预措施: Fluoroscopic control (Radiation)
3D-planimetric Measurement
Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination)
干预措施: 3D-planimetric measurement (Device)
3D-planimetric Measurement
Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination)
干预措施: Fluoroscopic control (Radiation)
3D-planimetric Measurement
Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination)
干预措施: Endoscopic control (Diagnostic Test)
Conventional Measurement
Esophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only
干预措施: Endoscopic control (Diagnostic Test)
结局指标
主要结局
Endoscopic therapy success
时间窗: 3 months after intervention at endoscopic control examination
Change in esophageal diameter \[mm\] and length of esophageal stricture \[cm\] after endoscopic therapy
次要结局
- Length measurement of esophageal stenosis(during endoscopic intervention)
- Postinterventional esophageal diameter(directly after endoscopic intervention)
- Hospitalization time after endoscopic dilatation therapy(within 3 months after study intervention)
- Number of endoscopic interventions(within 3 months after study intervention)
- Number of hospitalizations due to complications(within 3 months after initial study intervention)
- Quality of life assessed by German Sydney Swallow Questionnaire(Baseline study intervention and 2 weeks after study intervention)
- Complication rate(during the procedure)
- Duration of endoscopic examination(during the procedure)
- Sedation dose(during the procedure)
研究者
Thomas Seufferlein
Prof. Dr.
University of Ulm