A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy and safety of POEM in patients with postfundoplication dysfagia
研究概览
简要总结
Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.
- •Refractory (> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.
- •X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial/total stagnation of the contrast solution above the GEJ
- •Endoluminal planimetry: EGJ-DI < 3 mm2/mmHg (with 40ml)
- •Age above 18 years
- •Signed informed consent form
排除标准
- •No previous attempt with at least one prokinetic drug
- •Previous esophageal myotomy (open, laparoscopic or endoscopic)
- •Primary esophageal motility disorder (achalasia etc.)
- •Active erosive esophagitis
- •Active peptic ulcer disease
- •Esophageal stricture (peptic, malignant, other)
- •Partial or complete supradiaphragmatic migration of the wrap and/or stomach (Hinder Type III - IV), Large hiatal hernia more than 5 cm
- •Known eosinophilic esophagitis
- •Severe coagulopathy
- •Esophageal or gastric varices
- •Advanced liver cirrhosis (Child B or Child C)
- •Pregnancy or puerperium
- •Malignant or pre-malignant esophageal diseases (dysplasia): patients with a history of such disease after its cure are eligible for enrolment
- •Any other condition, which in the opinion of the investigator would interfere with study requirements
- •Known gastroparesis
研究组 & 干预措施
POEM arm
Patients, who will undergo peroral endoscopic myotomy for postfundoplication dysphagia
干预措施: Per Oral Endoscopic Myotomy (POEM) (Procedure)
结局指标
主要结局
Efficacy and safety of POEM in patients with postfundoplication dysfagia
时间窗: 6 months
The primary outcome will be proportion of patients with treatment success defined as Eckardt score ≤ 2 and its decrease by at least 1 point after POEM at 6 months
次要结局
- Eckardt score(At and after 3 and 12 months)
- Mellow - Pinkas score(At baseline and after 3, 6 and 12 months)
- PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life)(At baseline and after 3, 6 and 12 months)
- GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life)(At baseline and after 3, 6 and 12 months)
- Integrated Relaxation Pressure (IRP)(At baseline and after 6 months)
- Endoluminal planimetry (Endoflip)(At baseline and after 6 months)
- Esophagogram(At baseline and after 6 months)
- GERD(At baseline and after 3, 6 and 12 months)
- Esophageal 24h-Hour pH metry(At 3 months after procedure)
- PPI/H2 antagonists(At baseline and after 3, 6 and 12 months)
- Eckardt score(At baseline and after 3, 6 and 12 months)
研究者
Prof. Jan Martinek, MD, PhD, AGAF
Head of Gastroenterology and hepatology department
St. Anne's University Hospital Brno, Czech Republic