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临床试验/NCT04798547
NCT04798547已完成不适用

Outcomes of Short-length vs Standard-length Myotomy Using Per-Oral Endoscopic Myotomy (POEM) for Achalasia: A Randomized Controlled Pilot Study

Northwestern University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Compare symptomatic improvement of achalasia based on Eckardt Score following POEM with 4 cm myotomy vs 8 cm myotomy

研究概览

简要总结

The objective of this randomized controlled trial (non-inferiority study) is to evaluate the outcomes of 4 cm short myotomy compared to the 8 cm standard length myotomy in Per-Oral Endoscopic Myotomy (POEM) for patients with achalasia. We hypothesize that a shorter myotomy with POEM will have the same clinical efficacy as standard length myotomy based on patient-reported Eckardt score with shorter procedure times and reduced complications.

详细描述

BACKGROUND:

Achalasia is a disorder of esophageal dysmotility characterized by dysfunctional peristalsis and increased lower esophageal sphincter (LES) tone. Achalasia is further divided into three subtypes using high-resolution manometry (HRM) following the Chicago Classification. Type I, or classic achalasia, and Type II achalasia are both characterized by aperistalsis and increased LES tone and are thought to be a spectrum of the same disease process with Type II evolving into Type I.

Per-oral Endoscopic Myotomy (POEM) was first developed in 2008 as a treatment for achalasia. The technique involves a trans-oral approach with a flexible endoscope. An endoscopic incision is made in the esophagus and a submucosal tract is created towards the LES and gastric cardia to expose the underlying muscle of the LES and distal esophagus. The inner circular muscle is then dissected to create a myotomy and the tract is then closed with endoscopic clips. By creating a myotomy, the increased LES tone is improved, allowing food to pass into the stomach in order to relieve the dysphagia caused by achalasia.

Unlike Type III achalasia, where POEM myotomy length is determined by HRM, the standard myotomy length in Type I/Type II achalasia is typically 8 cm. The rationale for the 8 cm myotomy is derived from the Heller myotomy procedure which is a laparoscopic surgery approach in which the teaching has been to perform at least a 5 cm myotomy in the esophagus and an additional 2-3 cm myotomy in the gastric cardia. However, the purpose of the myotomy in POEM, is to reduce the LES tone. The clinical efficacy of the procedure comes from the myotomy of the high pressure zone within the LES, which is only 2-3cm in length. This is much shorter than the current standard POEM myotomy length. There are a few potential pitfalls regarding longer myotomy lengths in the esophagus and in the gastric cardia. A longer esophageal myotomy may result in esophageal wall strain in the area weakened by esophageal myotomy resulting in a blown out myotomy which is identified by the presence of a pseudo-diverticulum endoscopically. Longer gastric cardia myotomy has been thought to lead to an increased rate of gastroesophageal reflux in patients undergoing POEM. There are no data looking at shorter myotomy lengths in POEM for Type I and Type II achalasia. Our anecdotal experience at Northwestern when performing short myotomy during POEM has not resulted in any difference in procedural efficacy.

STUDY ENDPOINTS:

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients aged 18+ diagnosed with Type I or Type II achalasia, and patients with EGJ Outflow Obstruction with features of achalasia based on HRM or Endoscopic Functional Lumen Imaging Probe (EndoFLIP)
  • All subjects must have given signed, informed consent prior to registration in the study

排除标准

  • Patient with Type III achalasia or spastic esophageal dysmotility disorders requiring long myotomy as determined by HRM
  • All patients who are unable or unwilling to give consent will not be included in the study
  • Patients who are pregnant, vulnerable populations such as prisoners, life expectancy < 1 year based on concurrent comorbidities, coagulopathy with INR > 1.5 that cannot be reversed, thrombocytopenia with platelets < 50,000 that cannot be corrected with blood products, unable to safely undergo elective endoscopy due to current comorbidities, and inability to pass standard endoscope.
  • Patients who have already undergone treatment with POEM or Heller Myotomy

结局指标

主要结局

Compare symptomatic improvement of achalasia based on Eckardt Score following POEM with 4 cm myotomy vs 8 cm myotomy

时间窗: 2 years

At 1, 6 and 12 months, patient reported outcome of achalasia symptoms will be assessed. The Eckardt Score is a validated research tool for achalasia symptoms. Scores range from 0-12. A higher score indicates worse symptoms. We will compare Eckardt Score pre-POEM and post-PEM at various time points.

次要结局

  • Compare procedure complications after 4 cm myotomy with POEM compared to 8 cm myotomy with POEM(1 year)
  • Compare procedural time and intra-procedural findings between 4 cm myotomy with POEM compared to 8 cm myotomy with POEM(1 year)
  • Compare post-POEM gastro-esophageal reflux between 4 cm myotomy and 8 cm myotomy using GERDQ assessment.(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Aziz Aadam

Associate Professor of Medicine

Northwestern University

研究点 (2)

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