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临床试验/NCT04229342
NCT04229342已完成不适用

Comparison of Gastroesophageal Reflux Between Conventional Versus Oblique Fibers Sparing Endoscopic Myotomy for Achalasia Cardia - A Randomized Controlled Trial

Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
114
试验地点
2
主要终点
Significant Reflux Esophagitis, Los Angeles grade (≥grade B)

研究概览

简要总结

In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. This is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.

详细描述

In this randomized trial, patients with idiopathic achalasia will undergo POEM using two techniques as follows. In the first technique, a conventional posterior POEM will be performed where the sling or oblique fibers will not be spared during POEM. Sling or oblique fibers will be recognized using the configuration of fibers below the gastroesophaeal junction and by identifying the border between the sling fibers and the circular fibers which is formed by the penetrating vessels. In the second group (Oblique fiber group), the sling fibers will be selectively spared and only the circular fibers will be spared.

The other steps of the POEM procedure will be the same as described in the standard technique of POEM. These include submucosal injection of saline mixed with indigo carmine dye, mucosal incision, submucosal tunneling using triangular knife in spray coagulation mode (Effect 2, Watts 50), myotomy extending upto 2-4 cm below the gastroesophageal junction and the closure of mucosal incision using endoclips.

Post POEM management: All the patients will be kept nil per oral for about 24-hours after the procedure. A timed barium swallow will be performed the next day and oral liquids will be started. A soft puried diet will be started from day 3 onwards.

Oral proton pump inhibitors (PPIs) equivalent to 40 mg of Pantoprazole per day will be prescribed to all the patients unless a contraindication exists.

Follow-up: The first evaluation will be performed at 2-months after POEM. During this evaluation, the following parameters will be recorded: symptom relief, reflux symptoms, and esophageal acid exposure. PPIs will be stopped for 1-2 weeks prior to the evaluation of GERD.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with type 1 and 2 achalasia with Eckardt score >3 (0-12 scale achalasia).
  • Patients with age 18-75 years.
  • Patients who are treatment naïve or have a history of pneumatic balloon dilatation.
  • Patients who are willing and able to comply with the study procedures and provide written informed consent form to participate in the study

排除标准

  • Patients with type 3 achalasia cardia or any other esophageal motility disorder,
  • Patients who have undergone previous surgery of the esophagus or stomach,
  • Patients with active severe esophagitis,
  • Patients with large lower esophageal diverticula,
  • Patients with large ( > 3cm ) hiatal hernia,
  • Patients with sigmoid oesophagus,

结局指标

主要结局

Significant Reflux Esophagitis, Los Angeles grade (≥grade B)

时间窗: 8 weeks

Assessment of reflux esophagitis will be done at 8 weeks post procedure using Los Angeles grading system (grade A to D)

次要结局

  • Clinical success using Eckardt Score (minimum:0, maximum: 12)(6 months)
  • Reflux Symptoms, GERD HRQL score (minimum score: 0, maximum score: 50)(8-weeks)
  • Barium column height on Timed barium swallow; Success: >50% reduction in barium column height(2 months)
  • Gastroesophageal reflux with DeMeester score at 8-weeks: DeMeester score≥14.7 abnormal, <14.7: normal(8 weeks)
  • Esophageal manometry(8 weeks)
  • Clinical Success, Eckardt Score (minimum: 0, maximum: 12), Eckardt Score≤3: success, >3: failure(8 weeks)
  • Esophageal acid exposure, Acid exposure time>6 abnormal, <4: normal, 4-6: inconclusive(8 weeks)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

Principal Investigator

Asian Institute of Gastroenterology, India

研究点 (2)

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