About this trial
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)
Eligibility criteria
Qualifiers
Adults aged >18 years.
Diagnosis of Type II achalasia naïve patients based on high-resolution manometry (Chicago Classification v4).
Eckardt score >3.
Written informed consent
Disqualifiers
Type I or III achalasia.
Previous endoscopic or surgical treatment for achalasia.
Contraindications for POEM (e.g., coagulopathy, portal hypertension).
Sigmoid Achalasia
Trial design
Treatments tested in this trial
- Arm A - Conventional POEM (Control Arm)
- Arm B - Standard Tunnel with EGJ complex-only Myotomy
- Arm C - Ultra-short Tunnel POEM with EGJ complex -only Myotomy