NCT04229342

Post-POEM GERD in Patients Undergoing Conventional Versus Oblique Fibers Sparing Posterior Myotomy for Achalasia Cardia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Subsequent evaluation will be at 6-months for reflux symptoms and symptoms of achalasia using Eckardt scores.

Conditions

• GERD

Interventions

Type	Name	Description
PROCEDURE	Per-oral endoscopic myotomy	Per-oral endoscopic myotomy (POEM) is an endoscopic modality for the management of achalasia cardia. In this study, we will evaluate the impact of two different techniques of posterior POEM on the incidence of gastroesophageal reflux disease (GERD). Posterior POEM will be performed using the standard technique. The myotomy beyond the GEJ will be different in the two groups. In one group, the sling fibers will not be spared from dissection and in the second group, the sling fibers will be selectively spared from myotomy.

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-07-16
• Completion: 2020-10-06
• First posted: 2020-01-18
• Last updated: 2024-04-19

Locations

1 site across 1 country: India