Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux

NCT05500196 | Completed DMC

• 1 other identifier: POEM 005
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Reflux

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Symptoms of Gastro esophageal reflux disease

  6 months

• High resolution manometry parameters(LES pressures and IRP)

  6 months

Study Arms (2)

Myotomy length

Extended myotomy \>2.5cm

Device: Per Oral Endoscopy Myotomy (POEM)

MYOTOMY LENGTH

Extended myotomy\>3

Device: Per Oral Endoscopy Myotomy (POEM)

Interventions

Per Oral Endoscopy Myotomy (POEM) DEVICE

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; Myotomy length

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology /Aig Hospitals

Hyderabad, Telangana, 500082, India

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Zaheer Nabi, MBBS MD DNB

  ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 15, 2022
• Study Start: July 7, 2021
• Primary Completion: January 10, 2024
• Study Completion: July 25, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Locations

IN (1)