Assessment of Safety and Outcomes in Patients Undergoing a Standard-of-care Combined POEM-TIF Procedure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Safety of POEM-TIF as assessed by the American Society of Gastrointestinal Endoscopy (ASGE) lexicon scoring system
研究概览
简要总结
Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless Fundoplication (TIF) has been introduced as the endoscopic gold standard for anti-reflux procedure. Recently, combined POEM-TIF has been performed successfully as a standard of care treatment for patients with severe GER after POEM. We aim to study the safety and feasibility of performing POEM-TIF (POEM and TIF in the same endoscopic session). This study will also put the groundwork for a randomized clinical trial to further study the clinical outcome of the POEM-TIF procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Adult patient age greater than 18 years old
- •Manometrically proven diagnosis of either type I or type II achalasia.
排除标准
- •Achalasia type III, or other esophageal dysmotility disorders.
- •Completion of POEM with evidence of mucosal injury or compromise
- •Previous surgery of the stomach such as sleeve gastrectomy, gastric bypass, Heller myotomy, partial or complete fundoplication, or partial/complete gastrectomy
- •Esophageal lumen diameter greater than 4 cm
- •Sigmoidization of the esophagus
- •Large esophageal diverticula
- •Known active gastroesophageal malignancy
- •Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
- •Cirrhosis with portal hypertension, varices, and/or ascites
- •Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- •Acute gastrointestinal bleeding
- •Uncorrectable coagulopathy defined by international normalized ratio (INR) > 1.5 or platelet < 50,000
结局指标
主要结局
Safety of POEM-TIF as assessed by the American Society of Gastrointestinal Endoscopy (ASGE) lexicon scoring system
时间窗: 6 months
Safety will be evaluated by the frequency of severe adverse events with probable or definite attribution to the procedure based the ASGE lexicon scoring system. ASGE lexicon's severity grading system classify the adverse events into one of the four categories of mild, moderate, severe, and fatal. Mild adverse event means an adverse event that result in (1) Procedure aborted (or not started) because of an adverse event, (2) Post-procedure medical consultation, or (3) Unplanned hospital admission or prolongation of hospital stay for lesser or equal to 3 nights. Fatal grade adverse event happens when the procedure cause death.
次要结局
未报告次要终点