GERDPOEMNCT04229342
Post-POEM GERD in Patients Undergoing Conventional Versus Oblique Fibers Sparing Posterior Myotomy for Achalasia Cardia
A study testing Per-oral endoscopic myotomy in people with GERD, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- GERD
- What is being tested?
- Per-oral endoscopic myotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteIndia
- Study dates
- 6 Jan 2020to 6 Oct 2020
- Phase
- Interventional
- 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
Who may be able to join
- Patients with type 1 and 2 achalasia with Eckardt score >3 (0-12 scale achalasia).
- Patients with age 18-75 years.
- Patients who are treatment naïve or have a history of pneumatic balloon dilatation.
- Patients who are willing and able to comply with the study procedures and provide written informed consent form to participate in the study
Who cannot join
- Patients with type 3 achalasia cardia or any other esophageal motility disorder,
- Patients who have undergone previous surgery of the esophagus or stomach,
- Patients with active severe esophagitis,
- Patients with large lower esophageal diverticula,
- Patients with large ( > 3cm ) hiatal hernia,
- Patients with sigmoid oesophagus,
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: Comparison of Gastroesophageal Reflux Between Conventional Versus Oblique Fibers Sparing Endoscopic Myotomy for Achalasia Cardia - A Randomized Controlled Trial
In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. This is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.
Read the detailed description
In this randomized trial, patients with idiopathic achalasia will undergo POEM using two techniques as follows. In the first technique, a conventional posterior POEM will be performed where the sling or oblique fibers will not be spared during POEM. Sling or oblique fibers will be recognized using the configuration of fibers below the gastroesophaeal junction and by identifying the border between the sling fibers and the circular fibers which is formed by the penetrating vessels. In the second group (Oblique fiber group), the sling fibers will be selectively spared and only the circular fibers will be spared.
The other steps of the POEM procedure will be the same as described in the standard technique of POEM. These include submucosal injection of saline mixed with indigo carmine dye, mucosal incision, submucosal tunneling using triangular knife in spray coagulation mode (Effect 2, Watts 50), myotomy extending upto 2-4 cm below the gastroesophageal junction and the closure of mucosal incision using endoclips.
Post POEM management: All the patients will be kept nil per oral for about 24-hours after the procedure. A timed barium swallow will be performed the next day and oral liquids will be started. A soft puried diet will be started from day 3 onwards.
Oral proton pump inhibitors (PPIs) equivalent to 40 mg of Pantoprazole per day will be prescribed to all the patients unless a contraindication exists.
Follow-up: The first evaluation will be performed at 2-months after POEM. During this evaluation, the following parameters will be recorded: symptom relief, reflux symptoms, and esophageal acid exposure. PPIs will be stopped for 1-2 weeks prior to the evaluation of GERD.
Subsequent evaluation will be at 6-months for reflux symptoms and symptoms of achalasia using Eckardt scores.
- Conditions
- GERD
- Being tested
- Per-oral endoscopic myotomy
- 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 endoscopic myotomyProcedure or surgery
Per-oral endoscopic myotomy (POEM) is an endoscopic modality for the management of achalasia cardia. In this study, we will evaluate the impact of two different techniques of posterior POEM on the incidence of gastroesophageal reflux disease (GERD).
Posterior POEM will be performed using the standard technique. The myotomy beyond the GEJ will be different in the two groups. In one group, the sling fibers will not be spared from dissection and in the second group, the sling fibers will be selectively spared from myotomy.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | In the "conventional group", standard posterior myotomy will be performed and the sling or the oblique fibers will not be spared beyond the gastroesophageal junction. Receives: Procedure: Per-oral endoscopic myotomy |
| Oblique or sling fiber sparing group | Experimental | In the oblique or sling fiber group, only the circular muscle fibers will be severed selectively and the sling fibers will be spared Receives: Procedure: Per-oral endoscopic myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant Reflux Esophagitis, Los Angeles grade (≥grade B)
Assessment of reflux esophagitis will be done at 8 weeks post procedure using Los Angeles grading system (grade A to D)
Measured: 8 weeks
Secondary outcomes (7)
Clinical Success, Eckardt Score (minimum: 0, maximum: 12), Eckardt Score≤3: success, >3: failure
Clinical success will be evaluated using Eckardt scores
Measured: 8 weeks
Clinical success using Eckardt Score (minimum:0, maximum: 12)
Clinical success will be evaluated using Eckardt scores. Eckardt Score≤3 will be considered as clinical success and >3 will be considered as clinical failure
Measured: 6 months
Esophageal manometry
Esophageal manometry will be performed at 8 weeks and Integrated relaxation pressure will be calculated and presented in mmHg 5. Change in IRP pressure by Manometry ( Assessed at pre procedure \& 8 weeks).
Measured: 8 weeks
Barium column height on Timed barium swallow; Success: >50% reduction in barium column height
Timed barium swallow will be performed after POEM procedure and Esophageal emptying will be seen and compared with pre-POEM timed barium esophagogram
Measured: 2 months
Esophageal acid exposure, Acid exposure time>6 abnormal, <4: normal, 4-6: inconclusive
24-hour pH impedance study will be performed at 8-weeks and esophageal acid exposure will be calculated
Measured: 8 weeks
Reflux Symptoms, GERD HRQL score (minimum score: 0, maximum score: 50)
The symptoms of gastroesophageal reflux will be evaluated using symptom scores.
Measured: 8-weeks
Gastroesophageal reflux with DeMeester score at 8-weeks: DeMeester score≥14.7 abnormal, <14.7: normal
DeMeester scores will be calculated at 8 weeks after the POEM procedure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start6 Jan 2020
- Primary completion16 Jul 2020
- Study completion6 Oct 2020
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 GERDStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 114 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
- Dr. Vincy Chandran, MBBS,MD, Principal investigator, Asian Institute of Gastroenterology Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229342
- Sponsor's protocol ID
- POEM001
- Acronym
- POEM
- Status last verified
- Oct 2020
- First submitted
- 7 Jan 2020
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nabi Z, Chandran V, Basha J, Ramchandani M, Inavolu P, Kalpala R, Goud R, Jagtap N, Darisetty S, Gupta R, Tandan M, Lakhtakia S, Kotla R, Devarasetty R, Rao GV, Reddy DN. Conventional versus oblique fiber-sparing endoscopic myotomy for achalasia cardia: a randomized controlled trial (with videos). Gastrointest Endosc. 2024 Jan;99(1):1-9. doi: 10.1016/j.gie.2023.08.007. Epub 2023 Aug 19.
PubMed 37598863
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gastroesophageal Reflux Between Conventional Versus Oblique Fibers Sparing Endoscopic Myotomy for Achalasia Cardia - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04229342
- Acronym / sponsor ID
- POEM / POEM001
- Conditions
- GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 16 Jul 2020 (actual)
- Study completion
- 6 Oct 2020 (actual)
- First posted
- 18 Jan 2020 (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.
In this study, we will evaluate the incidence of reflux esophagitis between two different techniques of posterior per-oral endoscopic myotomy (POEM) i.e. conventional POEM versus oblique/ sling fiber sparing POEM. This is a randomized trial where the patients with idiopathic achalasia will be randomized in two groups in 1:1 fashion into groups.
Detailed description
In this randomized trial, patients with idiopathic achalasia will undergo POEM using two techniques as follows. In the first technique, a conventional posterior POEM will be performed where the sling or oblique fibers will not be spared during POEM. Sling or oblique fibers will be recognized using the configuration of fibers below the gastroesophaeal junction and by identifying the border between the sling fibers and the circular fibers which is formed by the penetrating vessels. In the second group (Oblique fiber group), the sling fibers will be selectively spared and only the circular fibers will be spared.
The other steps of the POEM procedure will be the same as described in the standard technique of POEM. These include submucosal injection of saline mixed with indigo carmine dye, mucosal incision, submucosal tunneling using triangular knife in spray coagulation mode (Effect 2, Watts 50), myotomy extending upto 2-4 cm below the gastroesophageal junction and the closure of mucosal incision using endoclips.
Post POEM management: All the patients will be kept nil per oral for about 24-hours after the procedure. A timed barium swallow will be performed the next day and oral liquids will be started. A soft puried diet will be started from day 3 onwards.
Oral proton pump inhibitors (PPIs) equivalent to 40 mg of Pantoprazole per day will be prescribed to all the patients unless a contraindication exists.
Follow-up: The first evaluation will be performed at 2-months after POEM. During this evaluation, the following parameters will be recorded: symptom relief, reflux symptoms, and esophageal acid exposure. PPIs will be stopped for 1-2 weeks prior to the evaluation of GERD.
Subsequent evaluation will be at 6-months for reflux symptoms and symptoms of achalasia using Eckardt scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: Per-oral endoscopic myotomyIn the "conventional group", standard posterior myotomy will be performed and the sling or the oblique fibers will not be spared beyond the gastroesophageal junction. |
| Oblique or sling fiber sparing group | Experimental | Procedure: Per-oral endoscopic myotomyIn the oblique or sling fiber group, only the circular muscle fibers will be severed selectively and the sling fibers will be spared |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with type 1 and 2 achalasia with Eckardt score >3 (0-12 scale achalasia).
- Patients with age 18-75 years.
- Patients who are treatment naïve or have a history of pneumatic balloon dilatation.
- Patients who are willing and able to comply with the study procedures and provide written informed consent form to participate in the study
Key exclusion criteria (6 listed)
- Patients with type 3 achalasia cardia or any other esophageal motility disorder,
- Patients who have undergone previous surgery of the esophagus or stomach,
- Patients with active severe esophagitis,
- Patients with large lower esophageal diverticula,
- Patients with large ( > 3cm ) hiatal hernia,
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 endoscopic myotomyPer-oral endoscopic myotomy (POEM) is an endoscopic modality for the management of achalasia cardia. In this study, we will evaluate the impact of two different techniques of posterior POEM on the incidence of gastroesophageal reflux disease (GERD). Posterior POEM will be performed using the standard technique. The myotomy beyond the GEJ will be different in the two groups. In one group, the sling fibers will not be spared from dissection and in the second group, the sling fibers will be selectively spared from myotomy. | Procedure or surgery | Conventional, Oblique or sling fiber sparing group |
Primary outcome
Significant Reflux Esophagitis, Los Angeles grade (≥grade B)
Time frame: 8 weeks
Assessment of reflux esophagitis will be done at 8 weeks post procedure using Los Angeles grading system (grade A to D)
7 secondary outcomes
Clinical Success, Eckardt Score (minimum: 0, maximum: 12), Eckardt Score≤3: success, >3: failure
Time frame: 8 weeks
Clinical success using Eckardt Score (minimum:0, maximum: 12)
Time frame: 6 months
Esophageal manometry
Time frame: 8 weeks
Barium column height on Timed barium swallow; Success: >50% reduction in barium column height
Time frame: 2 months
Esophageal acid exposure, Acid exposure time>6 abnormal, <4: normal, 4-6: inconclusive
Time frame: 8 weeks
Reflux Symptoms, GERD HRQL score (minimum score: 0, maximum score: 50)
Time frame: 8-weeks
Gastroesophageal reflux with DeMeester score at 8-weeks: DeMeester score≥14.7 abnormal, <14.7: normal
Time frame: 8 weeks
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 19 Apr 2024.
- Derived from this study: PubMed 37598863Nabi Z, Chandran V, Basha J, Ramchandani M, Inavolu P, Kalpala R, Goud R, Jagtap N, Darisetty S, Gupta R, Tandan M, Lakhtakia S, Kotla R, Devarasetty R, Rao GV, Reddy DN. Conventional versus oblique fiber-sparing endoscopic myotomy for achalasia cardia: a randomized controlled trial (with videos). Gastrointest Endosc. 2024 Jan;99(1):1-9. doi: 10.1016/j.gie.2023.08.007. Epub 2023 Aug 19.
- Individual participant dataSharing planned: No
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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.
Dr. Vincy Chandran, MBBS,MD principal investigator
Asian Institute of Gastroenterology Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Per-oral endoscopic myotomy in people with GERD, 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 4 inclusion and 6 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 19 Apr 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?
Significant Reflux Esophagitis, Los Angeles grade (≥grade B) (time frame: 8 weeks). 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 NCT04229342, 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 19 Apr 2024.