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

GERD Clinical Trial

— POEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04229342
• Other study ID #: POEM001
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: October 6, 2020

Study information

• Verified date: October 2020
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 6, 2020
• Est. primary completion date: July 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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,

Related Conditions & MeSH terms

• Esophageal Achalasia
• GERD

Intervention

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.

Locations

Country	Name	City	State
India	Asian institute of Gastroenterology/AIG Hospitals	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical Success, Eckardt Score (minimum: 0, maximum: 12), Eckardt Score=3: success, >3: failure	Clinical success will be evaluated using Eckardt scores	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Reflux Symptoms, GERD HRQL score (minimum score: 0, maximum score: 50)	The symptoms of gastroesophageal reflux will be evaluated using symptom scores.	8-weeks
Secondary	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