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

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)

Conditions

• Esophageal Diseases

Interventions

PROCEDURE

Arm A - Conventional POEM (Control Arm)

Arm A - Conventional POEM (Control Arm) * Tunnel Length: 10-12 cm submucosal tunnel, extending from 10 cm proximal to the EGJ into the proximal stomach. * Myotomy: * Esophageal segment: 6-8 cm * Gastric segment: 2 cm * Myotomy orientation: posterior (5-6 o'clock position) * Depth: selective circular myotomy in Esophageal segment, full-thickness at LES and gastric side

PROCEDURE

Arm B - Standard Tunnel with EGJ complex-only Myotomy

* Tunnel Length: 10-12 cm submucosal tunnel to allow full-length inspection and safe scope manipulation. * Myotomy: * Esophageal: 2 cm proximal to EGJ * Gastric: 2 cm distal to EGJ * Purpose: limit disruption of Esophageal muscle above EGJ while retaining effective LES division * Myotomy is confined to the EGJ complex while still using a standard tunnel * Full-thickness myotomy may be used at the EGJ for consistency

PROCEDURE

Arm C - Ultra-short Tunnel POEM with EGJ complex -only Myotomy

* Tunnel Length: Approximately 4 cm, just enough to reach the EGJ complex and enable targeted dissection * Myotomy: * Esophageal: 2 cm * Gastric: 2 cm * Only the EGJ segment is divided, minimising disruption of proximal Esophageal musculature * Myotomy is performed selectively along the posterior axis (5-6 o'clock) Intraoperative Assessment and Quality Control * Adequacy of gastric extension is confirmed with visualisation of retroflexed scope or via second scope trans illumination when needed. * Any bleeding is controlled with coagulation graspers or cautery. * Tunnelling is performed closely along the Muscularis propria to minimise mucosal injury. * The scope is periodically withdrawn for mucosal inspection during the procedure.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India

  lead OTHER

Principal Investigators

• Dr.Mohan Kumar Ramchandani, MD, DM · AIG Hospitals

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-31

Primary Completion

2027-06-20

Completion

2027-07-30