Low-Dose Amitriptyline as Adjunct Therapy for Residual Symptoms Following Peroral Endoscopic Myotomy in Achalasia: A Prospective, Open-Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 82
- 试验地点
- 1
研究概览
简要总结
Peroral endoscopic myotomy (POEM) is a successful treatment for achalasia, but approximately 10 to 40 percent of patients experience residual symptoms like chest pain or dysphagia. These symptoms often occur without objective evidence of obstruction, suggesting visceral hypersensitivity. Low-dose amitriptyline is a neuromodulator with established efficacy in functional esophageal disorders. This randomized trial aims to evaluate if adding low-dose amitriptyline to standard acid suppression therapy improves symptoms better than acid suppression alone. We hypothesize that targeting hypersensitivity will significantly reduce the total Eckardt score over 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Age greater than or equal to 18 years.
- •Residual symptoms defined as an Eckardt score greater than or equal to 3 persisting at least 2 weeks following technically successful POEM.
- •Normal post-POEM Gastrografin swallow with no delay in esophageal clearance at 5 minutes.
- •No evidence of active inflammation or structural obstruction in upper GI endoscopy and manometry.
排除标准
- •Active reflux esophagitis Los Angeles grade B, C, or D on endoscopy.
- •Esophageal stricture.
- •Current use of antidepressants, antipsychotics, or other centrally acting medications.
- •History of major psychiatric illness requiring psychotropic medication.
- •Pregnant or lactating women.
- •Known hypersensitivity to tricyclic antidepressants.
- •Cardiac conduction abnormalities, arrhythmias, or baseline QTc prolongation greater than 450 ms.
研究者
Anand Kumar Raghavendran
Department of Medical Gastroenterology
