Comparing two surgical techniques for treating Type 2 Achalasia
Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients
NA · Asian Institute of Gastroenterology, India · NCT06870630
This study is testing two different surgical methods for treating Type 2 Achalasia to see which one works better and has fewer side effects.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Asian Institute of Gastroenterology, India (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Hyderabad, Telangana) |
| Trial ID | NCT06870630 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves randomly assigning eligible patients with Type 2 Achalasia to receive either a standard myotomy or a myotomy focused on the esophagogastric junction complex. The study aims to evaluate the incidence of reflux through 24-hour pH analysis and assess treatment success using the Eckardt score at a three-month follow-up. Additionally, it will analyze recovery of esophageal peristalsis, procedure time, adverse effects, hospital stay duration, and quality of life post-procedure. Participants and care providers will be blinded to the treatment allocation to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years diagnosed with Type 2 Achalasia based on high-resolution manometry.
Not a fit: Patients with Type 1 or Type 3 Achalasia, previous treatments for achalasia, or contraindications to the POEM procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with Type 2 Achalasia.
How similar studies have performed: Other studies have shown success with similar surgical approaches, indicating potential for effective treatment options.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult \>18 years * Diagnosis of Type 2 Achalasia cardia based on High resolution manometry. Exclusion Criteria: * Patients with Type 1 \& 3 ACHALASIA CARDIA * Patients with previous endoscopic or surgical treatment for achalasia * Patients with standard exclusion criteria for POEM procedure such as contraindication to general anesthesia, coagulopathy (international normalized ratio \> 1.5, platelet count \< 50 000/μL), portal hypertension, pregnancy, breast feeding women, and diffuse scarring in the esophagus due to previous surgery or radiation.
Where this trial is running
Hyderabad, Telangana
- Asian Institute of Gastroenterology /Aig Hospitals — Hyderabad, Telangana, India (RECRUITING)
Study contacts
- Principal investigator: Zaheer Dr Nabi, MBBS MD — AIG Hospitals
- Study coordinator: Rajesh Dr Goud, 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: Esophageal Diseases