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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Arm A - Conventional POEM (Control Arm)

    Procedure/Surgery

    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

  • Arm B - Standard Tunnel with EGJ complex-only Myotomy

    Procedure/Surgery

    * 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

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

    Procedure/Surgery

    * 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.

Treatment groups

636 Participants
are divided into 3 treatment groups
Group A: Arm A (Control Group)Other 1 intervention
Group B: Arm B (Standard Submucosal Tunnel + EGJ - complex only Myotomy)Active comparator 2 interventions
Group C: Arm C (Ultra-short Tunnel + EGJ- complex only Myotomy)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of Gastro esophageal Reflux disease (GERD) after poem

Comparison of gastroesophageal reflux disease incidence, assessed by manual review of esophageal acid exopsure and endoscopic findings, between conventional poem and two experimental short tunnel poem techinques in patients with type II achalasia

Time frame
At 12 weeks and 52 weeks post-procedure

Secondary outcomes

1

Eckardt symptom score

Clinical success assessed using the Eckardt Symptom Score, a validated symptom scoring system for achalasia. Scale range: 0 to 12 Score \< 3 indicates clinical success Higher scores indicate worse symptoms

Time frame
At 12 weeks and 52 weeks post-procedure
2

Total procedure time

Total duration of the POEM procedure measured from mucosal incision to mucosal closure, recorded in minutes.

Time frame
Periprocedural (during the procedure)
3

use of acid suppressants

Requirement for acid suppressive medications, including proton pump inhibitors (PPIs) or H2-receptor blockers, following the procedure.

Time frame
Up to 1 year post-procedure
4

severity of esophagitis

Severity of esophagitis assessed by upper gastrointestinal endoscopy using the Los Angeles Classification of Esophagitis: Scale: Grade A = mild Grade B = moderate Grade C = severe Grade D = very severe (Higher grades indicate more severe esophagitis.)

Time frame
At 12 weeks post procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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