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

Asian Institute of Gastroenterology, India

Status: Completed

Conditions: GERD

Treatments: Procedure: Per-oral endoscopic myotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04229342

POEM001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups

Conventional

Active Comparator group

Description:

In the "conventional group", standard posterior myotomy will be performed and the sling or the oblique fibers will not be spared beyond the gastroesophageal junction.

Treatment:

Procedure: Per-oral endoscopic myotomy

Oblique or sling fiber sparing group

Experimental group

Description:

In the oblique or sling fiber group, only the circular muscle fibers will be severed selectively and the sling fibers will be spared

Treatment:

Procedure: Per-oral endoscopic myotomy