Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

Gastric Reflux Clinical Trial

— IGL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05500196
• Other study ID #: POEM 005
• Status: Recruiting
• Start date: July 7, 2021
• Est. completion date: August 10, 2024

Study information

• Verified date: November 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: NAVEEN ADEPU, MBBS MD
• Phone: 04023378888
• Email: naveenadepu.dr[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: August 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Reflux
• Gastroesophageal Reflux

Intervention

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.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology Pvt Ltd/Aih 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	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
Primary	Ph metry test for gastroesophageal reflux	Significant esophageal acid exposure(> 6%)	6 months
Secondary	Symptoms of Gastro esophageal reflux disease	Health related quality of life questionaires or scores in numericals	6 months
Secondary	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