NCT06870630

Standard Versus Oesophago-gastric Junction Complex Myotomy for Treatment naïve Type 2 Achalasia Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

\- Consecutive eligible patients will be randomized in a 1:1 ratio to esophagogastric complex only myotomy or standard myotomy groups. Randomization is done according to the computer-generated algorithm. A clinical research coordinator will prepare the sealed randomization envelops and will hand over to the operating endoscopists before the beginning of the procedure. Written informed consent will be obtained from all participants. In this study, the participants and the care-provider assessing the clinical response to the POEM procedure at 3months will be blinded to the allocation.

Detailed description

. Primary objective - • To study the incidence of true reflux on 24 hour pH analysis with manual study. Secondary objective - * To analyse treatment success which is defined as Eckdart score \< 3 at follow up assessment ( 3rd month) * To analyse the recovery of peristalsis after POEM using High resolution manometry * To study total procedure time , intra operative adverse effects and duration of hospital stay. * Severity of oesophagitis * Presence of GERD symptoms based on GERD questionnaire \& Quality of life questionaire post procedure.

Conditions

• Esophageal Diseases

Interventions

Type	Name	Description
DEVICE	Per oral endoscopy myotomy	Poem procedure is meant for cutting of circular and longitudinal muscle fibers in esophagus to reduce the symptoms of dysphagia, regurgitation and chestpain, weight loss.

Timeline

• Start date: 2023-11-29
• Primary completion: 2025-06-14
• Completion: 2025-07-30
• First posted: 2025-03-11
• Last updated: 2025-06-10

Locations

1 site across 1 country: India