Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

Completed

• Conditions: Gastric Reflux
• Interventions: Device: Per Oral Endoscopy Myotomy (POEM)

• Registration Number: NCT05500196
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief 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

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 Timeline

• Study Start: 2021-07-07
• Study First Submitted: 2022-08-10
• Study First Submitted QC: 2022-08-10
• Study First Posted: 2022-08-15
• Primary Completion: 2024-01-10
• Status Verified: 2024-07
• Study Completion: 2024-07-25
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Myotomy length	Per Oral Endoscopy Myotomy (POEM)	Extended myotomy \>2.5cm
MYOTOMY LENGTH	Per Oral Endoscopy Myotomy (POEM)	Extended myotomy\>3

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asian Institute of Gastroenterology /Aig Hospitals; 🇮🇳 Hyderabad, Telangana, India