NL-OMON22452招募中不适用
Technical feasibility of the EsoFLIP Achalasia Dilation Balloon
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
O¡¯Dea, John, and Peter D. Siersema. "Esophageal dilation with integrated balloon imaging: initial evaluation in a porcine model." Therapeutic advances in gastroenterology 6.2 (2013): 109-114.
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients have to meet the following criteria:
- •-Between 18 and 70 years of age
- •-Diagnosed with achalasia by absence of peristalsis and impaired relaxation of the LES (during swallow-induced relaxation a residual pressure of ¡Ý10mmHg) on standard manometry
- •-Eckardt symptom score >3 at baseline (5) (Appendix I)
- •-Eligible for standard pneumatic balloon dilation therapy
- •-Patients have signed the informed consent form
- •-Patients are willing and able to fill out the questionnaires
排除标准
- •Patients will be excluded in case of:
- •-Previous invasive treatment for achalasia
- •-Pseudoachalasia
- •-Megaesophagus (diameter of ¡Ý7 cm)
- •-Altered anatomy of the esophagus due to surgery
- •-Barrett¡¯s epithelium (>M2; >C1) or any grade of dysplasia, seen during endoscopy or in a biopsy in the past six months
- •-A history of either suspected or confirmed esophageal cancer
- •-Confirmed eosinophilic esophagitis
- •-Liver cirrhosis, portal hypertension and/or esophageal varices
- •-Coagulopathy (INR>1.5, platelets<50.000/mm3) which has not been corrected prior to the procedure
- •-Any condition that, at the discretion of the principal investigator, would preclude participation in the trial
研究者
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