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

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

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.

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Procedure: Per-oral endoscopic myotomy

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.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Asian institute of Gastroenterology/AIG Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional; 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.	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.
Experimental: Oblique or sling fiber sparing group; In the oblique or sling fiber group, only the circular muscle fibers will be severed selectively and the sling fibers will be spared	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Success, Eckardt Score (minimum: 0, maximum: 12), Eckardt Score≤3: success, >3: failure	Clinical success will be evaluated using Eckardt scores	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	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).	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	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	8 weeks
Reflux Symptoms, GERD HRQL score (minimum score: 0, maximum score: 50)	The symptoms of gastroesophageal reflux will be evaluated using symptom scores.	8-weeks
Gastroesophageal reflux with DeMeester score at 8-weeks: DeMeester score≥14.7 abnormal, <14.7: normal	DeMeester scores will be calculated at 8 weeks after the POEM procedure	8 weeks

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Dr. Vincy Chandran, MBBS,MD, Asian Institute of Gastroenterology Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): July 16, 2020
• Study Completion (Actual): October 6, 2020

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophageal Achalasia
• Other Study ID Numbers: POEM001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No