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临床试验/CTRI/2021/07/035105
CTRI/2021/07/035105进行中(未招募)不适用

POEM : Short vs Long Esophageal Myotomy for Achalasia cardia. A Randomised Controlled trial â€

Dr Praveer rai1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年7月26日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
66
试验地点
1
主要终点
1.Non-inferiority of a Short-POEM compared to a Long-POEM

研究概览

简要总结

Peroral Endoscopic Myotomy (POEM) has been recently introduced for treatment of achalasia, based on technical developments from NOTES (natural orifice translumenal surgery)[1]. 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[2,3]. The primary goal of treatment of achalasia cardia (either LHM or POEM) is to divide the muscle at LES to reduce the pressure so that food bolus can pass down into the esophagus. However, there is little evidence regarding the optimal length of this myotomy for either procedure[4]. During LHM the proximal length of myotomy is extended upto 6-8 cm in esophagus and distally to 3 cmin stomach. There are no data on long term outcomes between differential proximal myotomy lengths. The conventionally the esophageal myotomy is extended to 6-8 cm, this is based on technical considerations, as it is the maximum length that can safely be achieved via a laparoscopic, transhiatal approach [5]. High pressure zone of Esophago gastric junction (EGJ) complex extends for 4 cm on an average with 2 cm on esophageal side. The clinical efficacy of POEM and surgical myotomy is more likely to be similar according to the most recent published series. It is hypothesized that If shorter proximal myotomy (SM) that ablates just the EGJ complex could achieve the same normalization of EGJ physiology as a longer one (LM), there could be several advantages to this modification. It will take less mediastinal dissection of the esophagus, potentially reducing the chances of esophageal perforation, vagal injury and pleural tears [6]. During POEM, a shorter myotomy would allow for creation of a shorter submucosal tunnel, decreasing operative time along with potentially decreasing the incidence of mucosal perforations, pneumothorax and pneumoperitoneum[7,8]. In this randomized controlled trial (non-inferiority trial) we evaluate the outcomes of POEM according to the length of the esophageal myotomy. Patients undergoing POEM for type I and type II Achalasia cardia will be randomised into 2 groups of short oesophageal (3 cm) and long oesophageal ( 6-8 cm) myotomy. During follow-up, High Resolution Manometry (HRM), Esophageal pH-monitoring study and Esophagogastroduodenoscopy (EGD) will be regularly performed and symptoms assessed with the use of the Eckardt score (ECKs). The main hypothesis is that the results of a SM are not inferior to the results of a LM.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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
  • Pregnancy or nursing
  • Type 3 I achalasia cardia or any other esophageal motility disorder
  • Active severe esophagitis,Eosinophilic esophagitis or Barrett Esophagus
  • large lower Esophageal diverticula, Esophageal stricture
  • Large > 3cm hiatal hernia
  • Sigmoid esophagus
  • known Gastro Esophageal malignancy Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
  • 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.

结局指标

主要结局

1.Non-inferiority of a Short-POEM compared to a Long-POEM

时间窗: 1 year

次要结局

  • 1. Basal Lower Esophageal Sphincter (LES) pressure(2. 4-second Integrated Relaxation Pressure (4sIRP))

研究者

发起方
Dr Praveer rai
申办方类型
Other [self]

研究点 (1)

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