NCT07325071

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

A Randomized Controlled Trial Comparing Conventional and Short Submucosal Tunnel Techniques in Type II Achalasia

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 636 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Detailed description

Achalasia type II is the most common manometric subtype and responds well to Peroral Endoscopic Myotomy (POEM). However, the optimal extent of submucosal tunneling and myotomy length for this population remains uncertain. Conventional POEM typically involves a 10-12 cm submucosal tunnel with a long esophageal myotomy (6-8 cm) and a 2-3 cm gastric extension. While effective, this approach may predispose patients to higher rates of post-procedure gastroesophageal reflux disease (GERD), mucosal injuries, and CO₂-related insufflation events due to more extensive dissection. Recent physiologic data from FLIP studies suggest that disrupting the esophagogastric junction (EGJ) complex alone-approximately 2 cm proximally and 2-3 cm distally-may be sufficient to normalize EGJ distensibility in achalasia. Additional proximal myotomy does not appear to improve compliance and may unnecessarily increase the risk of adverse events or compromise esophageal motor recovery. Emerging randomized studies have further shown that shorter esophageal myotomies (≤5 cm) can provide symptom relief comparable to standard approaches, with potentially lower reflux rates. This trial evaluates whether limiting myotomy to the EGJ complex, with or without a shorter submucosal tunnel, can reduce post-POEM GERD while maintaining clinical efficacy in Type II achalasia. The study uses a three-arm randomized controlled design comparing: Conventional POEM with long submucosal tunnel and long esophageal myotomy; Standard-length tunnel with EGJ-only myotomy, preserving proximal esophageal muscle while maintaining full tunnel access; Ultra-short tunnel POEM with EGJ-only myotomy, minimising dissection length and procedure time. All procedures follow standardized POEM steps, including mucosal entry, submucosal tunneling, myotomy, and mucosal closure. Technical variations between arms are restricted to tunnel length and myotomy extent. Myotomy is performed primarily on the posterior axis, with selective circular myotomy proximally and full-thickness division across the LES as clinically appropriate. Adequacy of gastric extension is confirmed visually, and all mucosal incisions are closed using through-the-scope clips. Intraoperative quality control measures include frequent mucosal inspection, careful dissection along the muscularis propria, and standard management of bleeding or capnoperitoneum. Participants are randomized in a 1:1:1 ratio using concealed allocation. Blinding of operators is not feasible, but outcome assessors, data collectors, and statisticians remain blinded to minimize detection and assessment bias. Post-procedure evaluation includes symptomatic scoring, endoscopy, manometry when applicable, and 24-hour pH impedance testing. GERD will be assessed both physiologically and via validated patient-reported measures. Adverse events will be systematically recorded using the AGREE classification. An independent Data and Safety Monitoring Board will conduct an interim analysis after 50% of participants complete 3-month follow-up, with pre-specified stopping rules for superiority, futility, or harm. The large sample size and three-arm design are intended to allow detection of clinically meaningful differences in GERD incidence while ensuring the trial remains adequately powered after accounting for anticipated non-compliance. This study aims to provide high-quality, comparative data on whether submucosal tunnel length and targeted myotomy at the EGJ can optimize outcomes for Type II achalasia. If shorter techniques demonstrate equivalent clinical success with lower GERD rates and fewer adverse events, they may represent a safer and more efficient modification of the standard POEM procedure.

Conditions

• Esophageal Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-31
• Primary completion: 2027-06-20
• Completion: 2027-07-30
• First posted: 2026-01-08
• Last updated: 2026-01-08