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

Asian Institute of Gastroenterology, India

Status: Completed

Conditions: Gastric Reflux

Treatments: Device: Per Oral Endoscopy Myotomy (POEM)

Study type: Observational

Funder types: Other

Identifiers

NCT05500196

POEM 005

Details and patient eligibility

About

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

Full 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

Enrollment: 86 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

Myotomy length

Description:

Extended myotomy \>2.5cm

Treatment:

Device: Per Oral Endoscopy Myotomy (POEM)

MYOTOMY LENGTH

Description:

Extended myotomy\>3

Treatment:

Device: Per Oral Endoscopy Myotomy (POEM)