Gastric RefluxIGLNCT05500196
Impact of Gastric Length of Myotomy During POEM on Gastroesophageal Reflux
An observational study of Gastric Reflux, run by Asian Institute of Gastroenterology, India at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Reflux
- What is being tested?
- Per Oral Endoscopy Myotomy (POEM)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 86 participants
- Where
- 1 siteIndia
- Study dates
- 7 Jul 2021to 25 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible cases with idiopathic achalasia(type I \& II) will be enrolled in the study
Who may be able to join
- Idiopathic achalasia (type I and II)
- Age ≥18 years
- Willing to provide informed consent and comply with the study protocol
Who cannot join
- Ineligibility for POEM procedure
- Spastic esophageal motility disorders
- Presence of esophageal diverticulum and hiatal hernia
- Prior hellers myotomy with or with out fundoplication
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, 500082
About this study
Official title: Impact of Gastric Length of Myotomy During Poem on Gastroesophageal Reflux : A Randomized Controlled Trial
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
Read more
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
Read the 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
- Conditions
- Gastric Reflux
- Being tested
- Per Oral Endoscopy Myotomy (POEM)
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Myotomy length | Extended myotomy >2.5cm Receives: Device: Per Oral Endoscopy Myotomy (POEM) | |
| MYOTOMY LENGTH | Extended myotomy>3 Receives: Device: Per Oral Endoscopy Myotomy (POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Ph metry test for gastroesophageal reflux
Significant esophageal acid exposure(> 6%)
Measured: 6 months
Secondary outcomes (2)
Symptoms of Gastro esophageal reflux disease
Health related quality of life questionaires or scores in numericals
Measured: 6 months
High resolution manometry parameters(LES pressures and IRP)
lower esophageal sphincter pressure will be assesed by mmhg, integrated resting pressure in mmhg units
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start7 Jul 2021
- Primary completion10 Jan 2024
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric RefluxStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Zaheer Nabi, MBBS MD DNB, Study director, ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500196
- Sponsor's protocol ID
- POEM 005
- Acronym
- IGL
- Status last verified
- Jul 2024
- First submitted
- 10 Aug 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nabi Z, Adepu N, Inavolu P, Samanta J, Rughwani H, Singh AP, Pal P, Darisetty S, Kotla R, Goud R, Kalpala R, Tandan M, Gupta R, Ramchandani M, Lakhtakia S, Reddy DN. Impact of gastric length of myotomy during POEM on the incidence of gastroesophageal reflux: A randomized controlled trial. Gastrointest Endosc. 2026 Sep 18:S0016-5107(26)07064-1. doi: 10.1016/j.gie.2026.09.018. Online ahead of print.
PubMed 42759727
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gastric Length of Myotomy During Poem on Gastroesophageal Reflux : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05500196
- Acronym / sponsor ID
- IGL / POEM 005
- Conditions
- Gastric Reflux
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myotomy length | – | Device: Per Oral Endoscopy Myotomy (POEM)Extended myotomy >2.5cm |
| MYOTOMY LENGTH | – | Device: Per Oral Endoscopy Myotomy (POEM)Extended myotomy>3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible cases with idiopathic achalasia(type I \& II) will be enrolled in the study
Key inclusion criteria (3 listed)
- Idiopathic achalasia (type I and II)
- Age ≥18 years
- Willing to provide informed consent and comply with the study protocol
Key exclusion criteria (4 listed)
- Ineligibility for POEM procedure
- Spastic esophageal motility disorders
- Presence of esophageal diverticulum and hiatal hernia
- Prior hellers myotomy with or with out fundoplication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Per Oral Endoscopy Myotomy (POEM)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. | Device | MYOTOMY LENGTH, Myotomy length |
Primary outcome
Impact of Gastric Length of myotomy during poem on Gastroesophageal reflux
Time frame: 6 months
incidence of reflux esophagitis >grade B in cases with standard and extended gastric myotomies after POEM
Ph metry test for gastroesophageal reflux
Time frame: 6 months
Significant esophageal acid exposure(> 6%)
2 secondary outcomes
Symptoms of Gastro esophageal reflux disease
Time frame: 6 months
High resolution manometry parameters(LES pressures and IRP)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 42759727Nabi Z, Adepu N, Inavolu P, Samanta J, Rughwani H, Singh AP, Pal P, Darisetty S, Kotla R, Goud R, Kalpala R, Tandan M, Gupta R, Ramchandani M, Lakhtakia S, Reddy DN. Impact of gastric length of myotomy during POEM on the incidence of gastroesophageal reflux: A randomized controlled trial. Gastrointest Endosc. 2026 Sep 18:S0016-5107(26)07064-1. doi: 10.1016/j.gie.2026.09.018. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaheer Nabi, MBBS MD DNB study director
ASIAN INSTITUTE OF GASTROENTEROLOGY/AIG HOSPITALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Reflux, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Gastric Length of myotomy during poem on Gastroesophageal reflux (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05500196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.