Endoscopic Treatment of Zenker's Diverticulum: a Prospective Observational Study Comparing Tunnelization (Z-POEM) Versus Non-Tunnelization Techniques
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 主要终点
- Symptomatic recurrence rate after endoscopic tunnelization therapy (Z-POEM) compared to non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.
研究概览
简要总结
Prospective comparative observational study in numerous reference centers in France, comparing Tunnelization (Z-POEM) versus Non-Tunnelization Techniques according to the usual practices. This is a prospective, comparative, observational, multicenter study with the primary objective of comparing the symptomatic recurrence rate one year after endoscopic tunnelization therapy (Z-POEM) versus non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symptomatic Zenker's diverticulum (Augsburg score ≥5 )
- •Diagnostic evaluation including esophagogastroduodenoscopy (EGD) and a barium swallow (TOGD) with measurement of the diverticulum's height.
- •Patient aged 18 years or older
- •Patient with ASA 1, ASA 2, ASA 3 status
- •No participation in another concurrent clinical study
排除标准
- •Patient under 18 years old
- •Patient with ASA 4 or ASA 5 status
- •Pregnant woman
- •Patient with coagulation disorders preventing the performance a polypectomy: PT < 50%, Platelets < 50,000/mm³, ongoing effective anticoagulation, or current clopidogrel use.
- •Patient who has already undergone initial endoscopic or surgical treatment for Zenker's diverticulum
结局指标
主要结局
Symptomatic recurrence rate after endoscopic tunnelization therapy (Z-POEM) compared to non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.
时间窗: 12 months
Symptomatic recurrence is defined by: Clinical resolution after endoscopic treatment, as assessed clinically at 3 months, with an Augsburg score \<5. Reappearance of clinical symptoms, following clinical resolution after endoscopic treatment, with an Augsburg score ≥5.
次要结局
- Complication rate associated with the endoscopic procedure(15 days)
- Clinical success rate after endoscopic treatment.(3 months)
- Variation in Augsburg score at different time points(3 months, 6 months, 12 months, and 24 months)
- Radiographic resolution rate of the diverticulum(3 months)
- Symptomatic Recurrence Rate Post-Treatment:(at 3, 6, 12, and 24 Months)
研究者
Bertrand Brieau
Medical doctor, Principal Investigator
Société Française d'Endoscopie Digestive