Achalasia CardiaNCT02025790
POEM Versus Pneumatic Dilatation in Achalasia Cardia
A study testing Per Oral Endoscopic Myotomy (POEM) and Pneumatic Dilatation in people with Achalasia Cardia, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Achalasia Cardia
- What is being tested?
- Per Oral Endoscopic Myotomy (POEM) and Pneumatic Dilatation
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2013to Dec 2015
- 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
- Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)
- Age 18-75 years
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study
Who cannot join
- Severe comorbid illness
- Previous esophageal or gastric surgery
- Pseudo achalasia
- Achalasia with esophageal diverticula
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Andhra Pradesh, 500082
D Nageshwar Reddy, MD, +914023378888, aigindia@yahoo.co.in
Mohan Ramchandani, MD, +914023378888, ramchandanimohan@gmail.com
About this study
Official title: A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia
The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.
Read the detailed description
Achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (LES). Achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. Endoscopic treatments of achalasia can be provided in the form of dilatation of the LES or cutting of muscle fibers (myotomy) of the esophagus and of the LES under endoscopic viewing. Dilatation in this trial is accomplished with rigiflex balloons and myotomy via Per Oral Endoscopic Myotomy (POEM). The effectiveness of treatment of achalasia using each method will be compared in this trial.
- Conditions
- Achalasia Cardia
- Being tested
- Per Oral Endoscopic Myotomy (POEM), Pneumatic Dilatation
- Keywords
- Achalasia, POEM, Pneumatic dilatation, Eckardt score
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per Oral Endoscopic Myotomy (POEM)Procedure or surgery
- Mucosal incision - After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 12 cm proximal to the gastroesophageal junction (GEJ).
- Submucosal tunneling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
- Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm.
- Long endoscopic myotomy is performed 10 cm proximal to GEJ extending
- Closure of mucosal entry: the mucosal incision is closed using hemostatic clips
Pneumatic DilatationProcedure or surgery
Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Group A - POEM | Experimental | Per Oral Endoscopic Myotomy for treatment of achalasia Receives: Procedure: Per Oral Endoscopic Myotomy (POEM) |
| Group B - Dilatation | Active comparator | - Pneumatic dilatation using a balloon for treatment of achalasia. Receives: Procedure: Pneumatic Dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Clinical success defined as reduction of Eckardt score (0-12 scale achalasia least-most severe) of achalasia to an Eckardt score of 3 or less post procedure
Measured: 3 months post procedure
Secondary outcomes (1)
Adverse events
All dilatation or POEM related adverse events, including type, required intervention, severity, time to resolution
Measured: 1 week post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achalasia CardiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nageshwar Reddy D, Asian Institute of Gastroenterology, India
- Investigators
- D Nageshwar Reddy, MD, Principal investigator, Asian Institute of Gastroenterology (AIG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025790
- Sponsor's protocol ID
- AIG-POEM-01
- Status last verified
- Dec 2013
- First submitted
- 31 Dec 2013
- Last updated
- 1 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial Comparing POEM to Pneumatic Dilatation for Treatment of Achalasia Cardia
- ClinicalTrials.gov ID
- NCT02025790
- Acronym / sponsor ID
- AIG-POEM-01
- Conditions
- Achalasia Cardia
- Keywords
- Achalasia, POEM, Pneumatic dilatation, Eckardt score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 Jan 2014 (estimated)
- 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.
The aim of this study is to compare efficacy of POEM and pneumatic dilatation in treatment of achalasia cardia.
Detailed description
Achalasia is an esophageal motility disorder which involves smooth muscle of the esophagus and the lower esophageal sphincter (LES). Achalasia causes difficulty swallowing, regurgitation, and sometimes chest pain and weight loss. Endoscopic treatments of achalasia can be provided in the form of dilatation of the LES or cutting of muscle fibers (myotomy) of the esophagus and of the LES under endoscopic viewing. Dilatation in this trial is accomplished with rigiflex balloons and myotomy via Per Oral Endoscopic Myotomy (POEM). The effectiveness of treatment of achalasia using each method will be compared in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - POEM | Experimental | Procedure: Per Oral Endoscopic Myotomy (POEM)Per Oral Endoscopic Myotomy for treatment of achalasia |
| Group B - Dilatation | Active comparator | Procedure: Pneumatic Dilatation- Pneumatic dilatation using a balloon for treatment of achalasia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Achalasia with Eckardt score at least 3 (0-12 scale achalasia least-most severe)
- Age 18-75 years
- Willing and able to comply with the study procedures and provide written informed consent form to participate in the study written informed consent form to participate in the study
Key exclusion criteria (5 listed)
- Severe comorbid illness
- Previous esophageal or gastric surgery
- Pseudo achalasia
- Achalasia with esophageal diverticula
- Pregnancy or lactation
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 Myotomy (POEM)* Mucosal incision - After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 12 cm proximal to the gastroesophageal junction (GEJ). * Submucosal tunneling. A long submucosal tunnel is created to 3 cm distal to the GEJ. * Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm. * Long endoscopic myotomy is performed 10 cm proximal to GEJ extending * Closure of mucosal entry: the mucosal incision is closed using hemostatic clips | Procedure or surgery | Group A - POEM |
| Pneumatic DilatationPneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute. | Procedure or surgery | Group B - Dilatation |
Primary outcome
Clinical success
Time frame: 3 months post procedure
Clinical success defined as reduction of Eckardt score (0-12 scale achalasia least-most severe) of achalasia to an Eckardt score of 3 or less post procedure
1 secondary outcome
Adverse events
Time frame: 1 week post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2014.
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Achalasia
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.
D Nageshwar Reddy, MD principal investigator
Asian Institute of Gastroenterology (AIG)
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 (POEM) and Pneumatic Dilatation in people with Achalasia Cardia, 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 5 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: status not confirmed, as of the sponsor's last update on 1 Jan 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact D Nageshwar Reddy, MD (+914023378888, aigindia@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical success (time frame: 3 months post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jan 2014.