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

Asian Institute of Gastroenterology, India114 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

114

Conditions

GERD

Interventions

Per-oral endoscopic myotomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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,

Locations (1)

Asian institute of Gastroenterology/AIG Hospitals

Hyderabad, Telangana, India

Outcomes

Primary Outcomes

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

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

Time frame: 8 weeks

Secondary Outcomes

Clinical Success, Eckardt Score (minimum: 0, maximum: 12), Eckardt Score≤3: success, >3: failure

Clinical success will be evaluated using Eckardt scores

Time frame: 8 weeks

Clinical success using Eckardt Score (minimum:0, maximum: 12)

Clinical success will be evaluated using Eckardt scores. Eckardt Score≤3 will be considered as clinical success and \>3 will be considered as clinical failure

Time frame: 6 months

Esophageal manometry

Esophageal manometry will be performed at 8 weeks and Integrated relaxation pressure will be calculated and presented in mmHg 5. Change in IRP pressure by Manometry ( Assessed at pre procedure \& 8 weeks).

Time frame: 8 weeks

Barium column height on Timed barium swallow; Success: >50% reduction in barium column height

Timed barium swallow will be performed after POEM procedure and Esophageal emptying will be seen and compared with pre-POEM timed barium esophagogram

Time frame: 2 months

Esophageal acid exposure, Acid exposure time>6 abnormal, <4: normal, 4-6: inconclusive

24-hour pH impedance study will be performed at 8-weeks and esophageal acid exposure will be calculated

Time frame: 8 weeks

Reflux Symptoms, GERD HRQL score (minimum score: 0, maximum score: 50)

Data from ClinicalTrials.gov

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