Randomized Clinical Trial Comparing Short Versus Long Oesophageal Myotomy in POEM for Achalasia Cardia.
Condition: Achalasia Cardia
MeSH terms: Esophageal Achalasia
Study type: Interventional

Summary: 
      Aim of this study is to compare the outcomes of a short esophageal myotomy extending from 3
      cm cephalad to the EGJ, to 3 cm distal to it with a long esophageal myotomy with an
      additional proximal extension (at least 6 cm cephalad to the EGJ, to 3 cm distal) for POEM
      procedures. Principle of POEM is to reduce pressure gradient across LES by Myotomy.
      Hypothesis is that performing short myotomy will result in similar efficacy in achalasia
      cardia while reducing the total time taken for the procedure and ultimately will result in
      less complications.
    

Detailed description: 
      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. During LHM the proximal length of myotomy is extended upto 6-8 cm in esophagus and
      distally to 3 cm in 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. High pressure zone of Esophago gastric
      junction (EGJ) complex extends for 4 cm on an average with 2 cm on esophageal side. It is
      hypothesized that If shorter proximal myotomy that ablates just the EGJ complex could achieve
      the same normalization of EGJ physiology as a longer one, 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. 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. Additionally, there is chance that many patients regain
      some esophageal peristalsis after both LHM and POEM. Patients undergoing POEM for type 1 and
      type 2 Achalasia cardia will be randomised into 2 groups of short oesophageal (3 cm) and long
      oesophageal ( 6-8 cm) myotomy.
    

Intervention name(s): Per oral endoscopic myotomy
Intervention type(s): Procedure
Intervention description(s): General anesthesia will be administered and an esophagogastroduodenoscopy will be performed. Mucosal incision proximal to the gastroesophageal junction (GEJ) will be identified depending on short or long myotomy. A 1.5- to 2-cm mucosal incision will be performed after raising a submucosal wheal. The endoscope will be inserted to create a submucosal tunnel with a combination of blunt dissection, carbon dioxide insufflation, hydro dissection and careful electrocautery. The tunnel will be extended past the GEJ, 3 cm onto the gastric cardia. after myotomy, the mucosal incision will then be closed using standard endoscopic clips.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Achalasia cardia; myotomy; Per oral endoscopic myotomy; laparoscopic fundoplication