Sling-Fiber Preservation POEM vs. Conventional POEM for Reducing Post-POEM GERD: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)
研究概览
简要总结
Peroral endoscopic myotomy (POEM) is an effective, minimally invasive treatment for achalasia, offering excellent rates of symptom relief. However, a significant drawback is the high incidence of gastroesophageal reflux disease (GERD) following the procedure. One proposed technical modification, the selective preservation of the sling fibers during gastric myotomy (SFP-POEM), may reduce this risk without compromising efficacy as compared to a conventional POEM procedure, which includes myotomy of the sling fibers. In this study, adults with achalasia will be randomly assigned to receive one of the two POEM technical approaches. Researchers will monitor whether preserving sling fibers reduces the rates of reflux esophagitis (classified as Los Angeles Grade B or higher) on follow-up endoscopy. Participants will be followed for up to 1 year after the procedure.
详细描述
Achalasia is a rare esophageal motility disorder treated effectively with peroral endoscopic myotomy (POEM). However, post-procedure gastroesophageal reflux disease (GERD) is a common complication, reported in up to 65% of cases. One proposed technical modification - the selective preservation of gastric sling fibers - may help reduce reflux by maintaining part of the native anti-reflux mechanism.
This is a single-blinded, multicenter randomized controlled trial comparing sling fiber preservation (SFP) POEM versus conventional POEM in adult patients with achalasia. Patients are randomized 1:1 to either technique. The primary endpoint is the incidence of significant reflux esophagitis (LA esophagitis grade B or higher) at 3 months post-procedure endoscopy. Secondary outcomes include acid exposure time on pH impedence monitoring, symptomatic reflux (GerdQ), PPI usage, technical and clinical success, and adverse events. Follow-up continues for 12 months.
The study aims to determine whether the SFP-POEM technique reduces acid reflux without compromising treatment efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants are blinded to the intervention group. Endoscopists performing the procedure cannot be blinded.
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
- •(Participants must meet all of the following):
- •Age ≥ 18 years
- •Diagnosis of achalasia (Type I-III) per Chicago Classification v3.0
- •Deemed appropriate candidates for POEM
- •Ability to provide informed consent
排除标准
- •(Participants will be excluded if any of the following apply):
- •Spastic motility disorders other than achalasia type I-III (e.g. diffuse esophageal spasm, jackhammer esophagus, EGJ outflow obstruction)
- •Sigmoid esophagus
- •Prior surgical myotomy (e.g., Heller myotomy)
- •Contraindications to endoscopy or general anesthesia
- •Pregnancy or actively breastfeeding
- •Significant cardiopulmonary comorbidities that preclude safe endoscopic intervention
- •Coagulopathy or portal hypertension
- •Unwillingness or inability to complete follow-up assessments
研究组 & 干预措施
Conventional POEM
Participants in this arm will undergo standard peroral endoscopic myotomy (POEM), including myotomy of circular and sling muscle fibers at the gastric side.
干预措施: Conventional POEM (Procedure)
Sling Fiber-Preservation POEM
Participants in this arm will undergo posterior POEM with selective preservation of the gastric sling fibers. Myotomy is performed to the right of the second penetrating vessel to spare the sling fibers. The double scope technique will be employed to confirm that the tunnel ends on the lesser curve, which confirms sparing of the sling fibers.
干预措施: Sling Fiber-Preserving POEM (Procedure)
结局指标
主要结局
Incidence of Significant Reflux Esophagitis (Los Angeles Grade B or Higher)
时间窗: 3 months post-procedure
Reflux esophagitis will be assessed by upper endoscopy (EGD) at 3 months post-POEM. Grading will be based on the Los Angeles (LA) Classification. Significant reflux is defined as LA Grade B or higher.
次要结局
- Esophageal Acid Exposure(3 months post-procedure)
- Symptomatic Gastroesophageal Reflux (GerdQ Score)(3, 6, 12 months post-procedure)
- Proton Pump Inhibitor (PPI) Use(3, 6, 12 months post-procedure)
- Adverse Events(Within 1 month post-procedure)
- Esophageal Acid Exposure(3 months post-procedure)
- Symptomatic Gastroesophageal Reflux (GerdQ Score)(3, 6, 12 months post-procedure)
- Proton Pump Inhibitor (PPI) Use(3, 6, 12 months post-procedure)
- Clinical Success (Eckardt Symptom Score ≤ 3)(3, 6 and 12 months post-procedure)
- Technical Success(During procedure)
- Adverse Events(Within 1 month post-procedure)
研究者
Frances Dang
Assistant Clinical Professor
University of California, Irvine