Clinical Trial

Comparison of Conventional and Short Submucosal Tunnel Techniques in Type II Achalasia

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Summary
Rationale for This Study The primary rationale for this study is to evaluate whether a shorter submucosal tunnel during POEM with an EGJ-focused myotomy in type II Achalasia cardia patients, provides equivalent or superior symptom relief compared to the conventional approach while minimizing adverse events such as GERD \& blown out myotomy and decreasing the procedure time. Objectives Primary Objective: To compare the incidence of GERD (with manual review) at 3 and 12 months' post-procedure between conventional POEM and two experimental short-tunnel POEM techniques in patients with Type II achalasia. Secondary Objectives: To evaluate 1. Clinical success based on Eckardt score 2. Operating total procedure time 3. Use of Acid Suppressants on Follow up at 1 year 4. Severity of Esophagitis at 3 months 5. Intraoperative \& Postoperative adverse events (AGREE classification), 6. GERD-HRQL (0-18) scores 3 \& 12 Months 7. (Clinically relevant GORD was defined as excessive oesophageal /AET associated with a GERDQ score \>7 and/or with any grade of reflux oesophagitis). 8. Duration of Hospital stay 9. Quality of life (SF36)
Trial Details
NCT Number NCT07325071
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions Esophageal Diseases
Enrollment 636 participants
Start Date 2025-12-31
Primary Completion 2027-06-20 (estimated)
Study Completion 2027-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-08