Esophagus DisorderNCT06815341
Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia: A Prospective Study
An observational study of Esophagus Disorder, run by Asian Institute of Gastroenterology, India at 2 sites in India.
Trial summary
Classification for Stasis Esophagitis: Grade I Grade II Grade III Vascular pattern Obscured Obscured Obscured Mucosal thickening No Yes Yes Ulceration No Yes Yes Nodularity No No Yes Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagus Disorder
- How many people
- 339 participants
- Where
- 2 sitesIndia
- Study dates
- 14 Aug 2021to 20 Apr 2025
- 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
- Adult, Older adult
Study population: 339 subjects
Who may be able to join
- Patients (between 18 to 75 years of age) who underwent POEM for achalasia or other esophageal motility disorders.
- Had a diagnosis of esophageal achalasia confirmed by High Resolution Manometry, barium esophagogram.
Who cannot join
- Patients who underwent treatment other than achalasia
- Lost to follow up patients.
- Incomplete clinical record patients
- Patients not willing to participate in the study
Trial locations and contacts
2 sites in 1 country.
India2 sites, 1 recruiting
- Completed
Asian institute of Gastroenterology/AIG Hospitals
Hyderabad, Telangana, 500079
- Recruiting
Asian Institute of Gastroenterology /Aig Hospitals
Hyderabad, Telangana, 500082
ZAHEER DR NABI, MBBS MDDNB, 04023378888, zaheernabi1978@gmail.com
About this study
Official title: Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia
Classification for Stasis Esophagitis:
Grade I Grade II Grade III Vascular pattern Obscured Obscured Obscured Mucosal thickening No Yes Yes Ulceration No Yes Yes Nodularity No No Yes
Read the detailed description
Predictors of Submucosal Fibrosis:
Various factors were analysed for prediction of SMF including age, gender, stasis esophagitis, type of achalasia, duration of disease, lower esophageal sphincter pressure (LESP), height of barium column on barium esophagogram and severity of symptoms (Eckardt score). Esophageal mucosa was graded for the severity of stasis esophagitis (grade I to grade III) based on vascular pattern, mucosal thickening, ulceration and nodularity. SMF was graded (I minimal, II moderate, III severe) according to mucosal lift, difficulty in entry, density of SM fibers, separation of mucosa and muscle.
- Conditions
- Esophagus Disorder
- Medical subject headings
- Esophageal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary aim of the study is to evaluate the predictors for Sub mucosal fibrosis in cases with achalasia cardia.
sub mucosal fibres determination in different muscles of esophagus
Measured: 100 minutes
Secondary outcomes (1)
: To improve the technical outcomes of per oral endoscopy myotomy
to know the efficacy of procedure
Measured: 100 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start14 Aug 2021
- Primary completion20 Feb 2025 (estimated)
- Study completion20 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus DisorderStudies 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
- 339 participants (estimated)
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 Dr Mohammed, MBBS MD, Principal investigator, AIG Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815341
- Sponsor's protocol ID
- SMF
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia
- ClinicalTrials.gov ID
- NCT06815341
- Acronym / sponsor ID
- SMF
- Conditions
- Esophagus Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 20 Apr 2025 (estimated)
- First posted
- 7 Feb 2025 (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.
Classification for Stasis Esophagitis:
Grade I Grade II Grade III Vascular pattern Obscured Obscured Obscured Mucosal thickening No Yes Yes Ulceration No Yes Yes Nodularity No No Yes
Detailed description
Predictors of Submucosal Fibrosis:
Various factors were analysed for prediction of SMF including age, gender, stasis esophagitis, type of achalasia, duration of disease, lower esophageal sphincter pressure (LESP), height of barium column on barium esophagogram and severity of symptoms (Eckardt score). Esophageal mucosa was graded for the severity of stasis esophagitis (grade I to grade III) based on vascular pattern, mucosal thickening, ulceration and nodularity. SMF was graded (I minimal, II moderate, III severe) according to mucosal lift, difficulty in entry, density of SM fibers, separation of mucosa and muscle.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 339 subjects
Key inclusion criteria (2 listed)
- Patients (between 18 to 75 years of age) who underwent POEM for achalasia or other esophageal motility disorders.
- Had a diagnosis of esophageal achalasia confirmed by High Resolution Manometry, barium esophagogram.
Key exclusion criteria (4 listed)
- Patients who underwent treatment other than achalasia
- Lost to follow up patients.
- Incomplete clinical record patients
- Patients not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary aim of the study is to evaluate the predictors for Sub mucosal fibrosis in cases with achalasia cardia.
Time frame: 100 minutes
sub mucosal fibres determination in different muscles of esophagus
1 secondary outcome
: To improve the technical outcomes of per oral endoscopy myotomy
Time frame: 100 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
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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 Dr Mohammed, MBBS MD principal investigator
AIG Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Disorder, run by Asian Institute of Gastroenterology, India at 2 sites 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 2 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: status not confirmed, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Rajesh Goud Mr Maragoni, M.Pharm, MBA (04023378888 ext. 531, rajeshgoud761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary aim of the study is to evaluate the predictors for Sub mucosal fibrosis in cases with achalasia cardia. (time frame: 100 minutes). 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 11 Feb 2025.