Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux (IGL)

Impact of Gastric Length of Myotomy During Poem on Gastroesophageal Reflux : A Randomized Controlled Trial

This observational study will be conducted among 43 patients of both sexes in each group Study participants will be of the age more than 18 years

• STUDY PROCEDURE-Pre-defined technique to avoid bias and confounding due to multiple factors
• All the poem procedures will be performed by posterior route
• Preservation of sling fibers will be attempted in all the cases to avoid heterogeneity
• Length of esophageal myotomy will be kept constant (4-6cm)
• Double scope technique will be utilized to confirm the gastric extent of myotomy

First evaluation at 1-month: based on Symptoms

• Second evaluation: at 6 months by

• Objective evaluation: UGI endoscopy, High resolution manometry, Timed barium swallow
• Eckardt score, GERD-HRQL
• 24-hour pH study with manual readings

Study Overview

• Status: Recruiting
• Conditions: Gastric Reflux
• Intervention / Treatment: Device: Per Oral Endoscopy Myotomy (POEM)

Detailed Description

• The primary outcome of the study is the incidence of significant reflux esophagitis (≥grade B) in cases with standard and extended gastric myotomies at 6 months after POEM

Secondary outcomes:

• Significant esophageal acid exposure (>6%) as defined by the revised Lyon consensus
• Symptoms of GERD (GERD HRQL)
• Clinical efficacy (Eckardt score≤3)
• Esophageal emptying at 5 minutes
• High resolution manometry parameters (LES pressures and Integrated relaxation pressure in mmhg units)
• All the secondary outcomes will be assessed at 6 months after poem procedure

Eligibility:

Eligible cases with idiopathic achalasia (type I and II) will be enrolled in the study and randomized (1:1 ratio) in two groups according to the length of gastric myotomies

INCLUSION CRITERIA :

• Idiopathic achalasia (type I and II)
• Age ≥18 years
• Willing to provide informed consent and comply with the study protocol

Exclusion criteria

• Ineligibility for POEM procedure
• Spastic esophageal motility disorders
• Presence of esophageal diverticulum and hiatal hernia
• Prior hellers myotomy with or with out fundoplication

• Study Type: Observational
• Enrollment (Estimated): 86

Contacts and Locations

• Study Contact: Name: NAVEEN ADEPU, MBBS MD; Phone Number: 04023378888; Email: naveenadepu.dr@gmail.com
• Study Contact Backup: Name: RAJESH GOUD, M.PHARMA, MBA, PGDM; Phone Number: 501 04023378888; Email: rajeshgoud761@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian Institute of Gastroenterology Pvt Ltd/Aih Hospitals
      • Contact: ZAHEER DR NABI, MBBS MDDNB; Phone Number: 04023378888; Email: zaheernabi1978@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Eligible cases with idiopathic achalasia(type I & II) will be enrolled in the study

Description

Inclusion Criteria:

• Idiopathic achalasia (type I and II)
• Age ≥18 years
• Willing to provide informed consent and comply with the study protocol

Exclusion Criteria:

• Ineligibility for POEM procedure
• Spastic esophageal motility disorders
• Presence of esophageal diverticulum and hiatal hernia
• Prior hellers myotomy with or with out fundoplication

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Myotomy length; Extended myotomy >2.5cm	Device: Per Oral Endoscopy Myotomy (POEM); POEM is a form of natural orifice transluminal endoscopic surgery that is completed by creating a submucosal tunnel in the lower part of esophagus to reach the inner circular muscle bundles of the LES to perform myotomy, while preserving the outer longitudinal muscle bundles. The result is decreased resting pressure of the LES, facilitating the passage of ingested material.
MYOTOMY LENGTH; Extended myotomy>4	Device: Per Oral Endoscopy Myotomy (POEM); POEM is a form of natural orifice transluminal endoscopic surgery that is completed by creating a submucosal tunnel in the lower part of esophagus to reach the inner circular muscle bundles of the LES to perform myotomy, while preserving the outer longitudinal muscle bundles. The result is decreased resting pressure of the LES, facilitating the passage of ingested material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Gastric Length of myotomy during poem on Gastroesophageal reflux	incidence of reflux esophagitis >grade B in cases with standard and extended gastric myotomies after POEM	6 months
Ph metry test for gastroesophageal reflux	Significant esophageal acid exposure(> 6%)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of Gastro esophageal reflux disease	Health related quality of life questionaires or scores in numericals	6 months
High resolution manometry parameters(LES pressures and IRP)	lower esophageal sphincter pressure will be assesed by mmhg, integrated resting pressure in mmhg units	6 months

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Study Director: Zaheer Nabi, MBBS MD DNB, Asian institute of Gastroenterology/AIG Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Estimated): January 10, 2024
• Study Completion (Estimated): August 10, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: POEM 005

Drug and device information, study documents

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