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

NCT07325071 | Not Yet Recruiting DMC

• 1 other identifier: TRIM POEM
• Study Type: interventional
• Target: 636
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Clinical success based on Eckardt score
2. 2.Operating total procedure time
3. 3.Use of Acid Suppressants on Follow up at 1 year
4. 4.Severity of Esophagitis at 3 months
5. 5.Intraoperative \& Postoperative adverse events (AGREE classification),
6. 6.GERD-HRQL (0-18) scores 3 \& 12 Months
7. 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. 8.Duration of Hospital stay
9. 9.Quality of life (SF36)

Conditions

Esophageal Diseases

Outcome Measures

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

  At 12 weeks and 52 weeks post-procedure

Secondary Outcomes (9)

• Eckardt symptom score

  At 12 weeks and 52 weeks post-procedure

• Total procedure time

  Periprocedural (during the procedure)

• use of acid suppressants

  Up to 1 year post-procedure

• severity of esophagitis

  At 12 weeks post procedure

• intraoperative and post operative adverse events

  Periprocedural and post-procedure

Study Arms (3)

Arm A (Control Group)

OTHER

Conventional POEM with 10-12 cm submucosal tunnel, 6-8 cm Esophageal myotomy, and 2 cm gastric myotomy

Procedure: Arm A - Conventional POEM (Control Arm)

Arm B (Standard Submucosal Tunnel + EGJ - complex only Myotomy)

ACTIVE COMPARATOR

10-12 cm submucosal tunnel with myotomy restricted to the EGJ (2 cm Esophageal and 2 cm gastric)

Procedure: Arm B - Standard Tunnel with EGJ complex-only Myotomy; Procedure: Arm C - Ultra-short Tunnel POEM with EGJ complex -only Myotomy

Arm C (Ultra-short Tunnel + EGJ- complex only Myotomy)

ACTIVE COMPARATOR

4 cm submucosal tunnel with myotomy focused on the EGJ (2 cm Esophageal and 2 cm gastric)

Procedure: Arm B - Standard Tunnel with EGJ complex-only Myotomy; Procedure: Arm C - Ultra-short Tunnel POEM with EGJ complex -only Myotomy

Interventions

Arm A - Conventional POEM (Control Arm) PROCEDURE

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 A (Control Group)

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

* 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 B (Standard Submucosal Tunnel + EGJ - complex only Myotomy); Arm C (Ultra-short Tunnel + EGJ- complex only Myotomy)

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

* 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.

Arm B (Standard Submucosal Tunnel + EGJ - complex only Myotomy); Arm C (Ultra-short Tunnel + EGJ- complex only Myotomy)

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Type I or III achalasia.
• Previous endoscopic or surgical treatment for achalasia.
• Contraindications for POEM (e.g., coagulopathy, portal hypertension).
• Sigmoid Achalasia

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Related Publications (2)

• Nabi Z, Talukdar R, Mandavdhare H, Reddy DN. Short versus long esophageal myotomy during peroral endoscopic myotomy: A systematic review and meta-analysis of comparative trials. Saudi J Gastroenterol. 2022 Jul-Aug;28(4):261-267. doi: 10.4103/sjg.sjg_438_21.

  PMID: 34806659 RESULT

• Stefanidis D, Richardson W, Farrell TM, Kohn GP, Augenstein V, Fanelli RD; Society of American Gastrointestinal and Endoscopic Surgeons. SAGES guidelines for the surgical treatment of esophageal achalasia. Surg Endosc. 2012 Feb;26(2):296-311. doi: 10.1007/s00464-011-2017-2. Epub 2011 Nov 2. No abstract available.

  PMID: 22044977 RESULT

MeSH Terms

Conditions

Esophageal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Dr.Mohan Kumar Ramchandani, MD, DM

  AIG Hospitals

  STUDY DIRECTOR

Central Study Contacts

Dr.Aniruddha Pratap singh, MD, DM

CONTACT

9004093248; Doc.aniruddha85@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DM, FJGES , Director interventional Endoscopy , senior consultant Gastroenterologist

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: January 8, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: January 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share