Transverse vs Longitudinal Mucosal Incision During POEM

Transverse Versus Longitudinal Mucosal Incision in Peroral Endoscopic Myotomy: A Multicenter Randomized Clinical Trial

Peroral endoscopic myotomy (POEM) is a minimally invasive endoscopic procedure used to treat achalasia and other spastic esophageal motility disorders. A key step in POEM is creating a small opening in the esophageal lining (mucosal incision) to enter the submucosal tunnel. This study evaluates whether making that entry incision **transverse** (across the esophagus) versus **longitudinal** (along the esophagus) improves procedural efficiency without reducing safety.

This is a **multicenter, randomized (1:1), parallel-group clinical trial** conducted in three therapeutic endoscopy units in Colombia (Hospital Universitario del Valle and Clínica Versalles in Cali, and Clínica del Occidente in Bogotá). Adults (≥18 years) with an indication for POEM, ASA I-III, and ability to provide informed consent will be eligible; key exclusions include prior myotomy/major esophageal surgery, uncorrectable coagulopathy, pregnancy, active systemic infection, anesthesia contraindication, or anticipated technical inability to perform POEM.

All procedures are standardized: POEM under **general anesthesia with orotracheal intubation**, **CO₂ insufflation**, validated endoscopic knives and preset electrosurgical modes; hemostasis with **Coagrasper® only if needed**; and closure using standard **through-the-scope (TTS) clips**. Participants are randomly assigned to a **15 mm transverse mucosal incision** (perpendicular to the esophageal axis) or a **15 mm longitudinal mucosal incision**. Full-procedure video is recorded for quality control and to allow objective timing, with blinded assessment of the primary outcome.

The **primary outcome** is the time (seconds) from the first mucosal cut to successful entry of the endoscope cap into the submucosal tunnel (advancing at least 1 cm). **Secondary outcomes** include need for hemostasis with Coagrasper®, number of clips required for complete closure, and early complications (including perforation and gas-related events such as capnoperitoneum requiring decompression and emphysema), monitored through **30 days**.

Participants complete a screening/preoperative visit (up to 30 days before), undergo the POEM procedure, have early in-hospital/discharge assessment (days 1-2), and receive safety follow-up contacts at approximately 1 week and day 30.

Risks are those expected from standard POEM and peri-anesthesia care (e.g., bleeding, perforation, infection, and gas-related complications), and participants may not directly benefit clinically. However, the transverse incision may shorten access and closure time and reduce resource use without increasing short-term complications.

The study will be conducted with written informed consent, confidentiality protections (pseudonymization and secure storage), and reporting of results in aggregate form.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Achalasia; Spastic Esophageal Motility Disorders
• Intervention / Treatment: Procedure: Transverse Mucosal Incision During POEM; Procedure: Longitudinal Mucosal Incision During POEM

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Juan P Alzate, MD, MsC; Phone Number: +573102587912; Email: jpalzategr@unal.edu.co

Study Locations

• Colombia
  • Bogotá, Colombia
    • Alzate
    • Contact: Juan P Alzate; Phone Number: +573102587912; Email: jpag6@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Diagnosis of achalasia or other spastic esophageal motility disorders with an indication for POEM
• ASA physical status I-III
• Ability to provide informed consent

Exclusion Criteria:

• Prior myotomy or major esophageal surgery
• Uncorrectable coagulopathy
• Pregnancy
• Active systemic infection
• Contraindication to anesthesia
• Any situation predicting technical inability to perform POEM

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transverse Mucosal Incision During POEM; POEM performed with a 15 mm transverse mucosal incision (perpendicular to the esophageal axis) for entry into the submucosal tunnel, under a standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded)	Procedure: Transverse Mucosal Incision During POEM; POEM performed with a 15 mm transverse mucosal incision (perpendicular to the esophageal axis) for entry into the submucosal tunnel, under a standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded).
Active Comparator: Longitudinal Mucosal Incision During POEM; POEM performed with a 15 mm longitudinal mucosal incision (parallel to the esophageal axis) for entry into the submucosal tunnel, under the same standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded)	Procedure: Longitudinal Mucosal Incision During POEM; POEM performed with a 15 mm longitudinal mucosal incision (parallel to the esophageal axis) for entry into the submucosal tunnel, under the same standardized POEM protocol (general anesthesia with orotracheal intubation, CO₂ insufflation, validated endoscopic knives/electrosurgical settings, hemostasis with Coagrasper® only if needed, and closure with TTS clips; full-procedure video recorded).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Effective Submucosal Tunnel Entry (Seconds)	Time (in seconds) from the first mucosal cut to effective entry of the endoscope cap into the submucosal tunnel, defined as allowing advancement of at least 1 cm.	During the POEM procedure (Day 0; intraoperative)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding Requiring Hemostasis With Coagrasper®	Proportion of procedures with bleeding that requires hemostasis using Coagrasper® (Yes/No).	During the POEM procedure (Day 0; intraoperative)
Procedure-Related Complications (Up to 30 Days)	Any complication related to the procedure, monitored through 30 days.	Up to 30 days after the procedure (contacts at ~1 week and Day 30; plus early assessment Days 1-2).

Collaborators and Investigators

• Sponsor: Universidad Nacional de Colombia
• Collaborators: Hospital San Rafael de Facatativá

Study record dates

Study Major Dates

• Study Start (Estimated): February 22, 2026
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): August 2, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Achalasia
• Other Study ID Numbers: DE-F-254-V8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No