Peroral Endoscopic Myotomy (POEM) for the Treatment of Esophageal Achalasia: Long vs Short Myotomy. Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Non-inferiority of a Short-POEM compared to a Long-POEM
研究概览
简要总结
Per-Oral Endoscopic Myotomy (POEM) is increasingly used for the treatment of achalasia. In published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter (8cm). The clinical efficacy of both procedure is comparable.
This study intends to investigate if clinical outcomes of POEM depends on the length of esophageal myotomy, in patients with classic-type achalasia (type I and type II according to Chicago Classification)
详细描述
Peroral Endoscopic Myotomy myotomy (POEM) has been recently introduced for treatment of achalasia, based on technical developments from NOTES (natural orifice translumenal surgery). The technique includes the incision of the mucosa in the esophageal body, the submucosal dissection of the distal esophagus and the creation of a submucosal tunnel in the distal esophagus and proximal gastric body, and the esophageal myotomy. The procedure is performed transorally, using a flexible endoscope.
In published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter, being protracted for about 8cm. The clinical efficacy of POEM and surgical myotomy is more likely to be similar according to the most recent published series.
In this randomized controlled trial (non-inferiority trial) we evaluate the outcomes of POEM according to the length of the esophageal myotomy.
Patients with type I and II achalasia will be randomly assigned to one of the two groups, long--myotomy (LM) and short--myotomy (SM).
Patients in the LM-group will receive a 12cm-long POEM (including 3cm on the stomach); in the SM-group patients will undergo a POEM extended for 7 cm (including 3cm on the stomach).
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
- 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
- •Diagnosis of achalasia (type I and II)
- •Signed informed consent
- •Patient accepts to undergo scheduled follow-up after POEM
- •Eckardt score > 3
- •ASA I-II-III
排除标准
- •Prior surgical treatment of achalasia (previous endoscopic balloon dilation or botox injection ARE NOT exclusion criteria)
- •Pregnancy or nursing
- •Current alcohol or drug addiction.
- •Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator make the subject a poor candidate for this study.
- •Severe congenital or acquired coagulopathy or INR > 1.6
- •Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
- •Hepatic cirrhosis w/ or w/o portal hypertension w/ or w/o esophageal varices
- •Eosinophilic esophagitis or Barrett Esophagus
- •Esophageal Strictures
结局指标
主要结局
Non-inferiority of a Short-POEM compared to a Long-POEM
时间窗: 2 years
Treatment success, defined as an Eckard score ≤ 3. The Eckardt score is a clinical score for evaluating the severity of achalasia-related symptoms. Eckardt score varies between 0 and 12. Questions are asked about the frequency of dysphagia, regurgitation and retrosternal pressure sensation. Depending on whether any of these symptom occurrs, never, occasionally, daily or with each meal, a symptom score between 0 and 3 is applied. In addition a symptom score of 0-3 is assigned to the degree of weight loss (0 - No weight loss; 1 - weight loss \< 5Kg, 2 - weight loss between 5 and 10Kg, 3- weight loss \> 10Kg). Each symptom score (dysphagia, regurgitation, retrosternal pressure, and wieight loss) is summed to the other. Thus, a completely asymptomatic patient has a score of 0 and the most severely affected patient had a maximum score of 12.
次要结局
- 4-second Integrated Relaxation Pressure (4sIRP)(Before POEM, 6 months and 2 years after the procedure)
- Esophageal pH-monitoring study(6 months after POEM)
- Basal Lower Esophageal Sphincter (LES) pressure(Before POEM, 6 months and 2 years after the procedure)
- Gastro-Esophageal Reflux (GER) symptom assessment(baseline, 6 months and 2 years after POEM)
- Operating time(During the endoscopic procedure)
- Side effects and complications(Baseline to 2 years)
- Quality of life(baseline, 6 months and 2 years)
研究者
Guido Costamagna
Professor
Catholic University of the Sacred Heart