Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05500196 |
Other study ID # |
POEM 005 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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