Clinical trial NCT05500196: Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux
Official title: Impact of Gastric Length of Myotomy During Poem on Gastroesophageal Reflux : A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Reflux
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible cases with idiopathic achalasia(type I \& II) will be enrolled in the study

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

Eligibility criteria: 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

Primary outcomes:
measure: Impact of Gastric Length of myotomy during poem on Gastroesophageal reflux
timeFrame: 6 months
measure: Ph metry test for gastroesophageal reflux
timeFrame: 6 months
Secondary outcomes:
measure: Symptoms of Gastro esophageal reflux disease
timeFrame: 6 months
measure: High resolution manometry parameters(LES pressures and IRP)
timeFrame: 6 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology /Aig Hospitals
state: Telangana
Study officials:
affiliation: ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS
name: Zaheer Nabi, MBBS MD DNB
role: STUDY_DIRECTOR
References: