Identifying risk factors for submucosal fibrosis in achalasia patients
Risk Factors for Sub Mucosal Fibrosis During Achalasia Cardia
Asian Institute of Gastroenterology, India · NCT06815341
This study is trying to find out what factors might increase the risk of submucosal fibrosis in people with achalasia and other esophageal motility disorders.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 339 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India (other) |
| Locations | 2 sites (Hyderabad, Telangana and 1 other locations) |
| Trial ID | NCT06815341 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify predictors of submucosal fibrosis (SMF) in patients with achalasia and other esophageal motility disorders. It analyzes various factors such as age, gender, stasis esophagitis severity, and lower esophageal sphincter pressure to determine their correlation with the development of SMF. The study also grades the severity of stasis esophagitis and SMF based on specific clinical criteria. By understanding these risk factors, the study seeks to improve patient management and outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 75 who have been diagnosed with esophageal achalasia and are undergoing peroral endoscopic myotomy (POEM).
Not a fit: Patients who have undergone treatments other than for achalasia or those with incomplete clinical records may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk assessment and management strategies for patients with achalasia, potentially improving their treatment outcomes.
How similar studies have performed: While this study focuses on a specific aspect of achalasia, similar studies have shown success in identifying risk factors for other esophageal disorders, suggesting potential for valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients who underwent treatment other than achalasia * Lost to follow up patients. * Incomplete clinical record patients * Patients not willing to participate in the study
Where this trial is running
Hyderabad, Telangana and 1 other locations
- Asian institute of Gastroenterology/AIG Hospitals — Hyderabad, Telangana, India (COMPLETED)
- Asian Institute of Gastroenterology /Aig Hospitals — Hyderabad, Telangana, India (RECRUITING)
Study contacts
- Principal investigator: Zaheer Nabi Dr Mohammed, MBBS MD — AIG Hospitals
- Study coordinator: Rajesh Goud Mr Maragoni, M.Pharm, MBA
- Email: rajeshgoud761@gmail.com
- Phone: 04023378888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophagus Disorder