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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-75
SponsorAsian Institute of Gastroenterology, India

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

Treatment groups

636 Participants
are divided into 3 treatment groups

Locations

This trial has no locations