Transverse vs Longitudinal Mucosal Incision During POEM

NCT07425977 | Not Yet Recruiting Phase 3

• 1 other identifier: DE-F-254-V8
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Achalasia; Spastic Esophageal Motility Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bleeding Requiring Hemostasis With Coagrasper®

  During the POEM procedure (Day 0; intraoperative)

• Procedure-Related Complications (Up to 30 Days)

  Up to 30 days after the procedure (contacts at ~1 week and Day 30; plus early assessment Days 1-2).

Study Arms (2)

Transverse Mucosal Incision During POEM

EXPERIMENTAL

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

Longitudinal Mucosal Incision During POEM

ACTIVE COMPARATOR

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

Interventions

Transverse Mucosal Incision During POEM PROCEDURE

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).

Transverse Mucosal Incision During POEM

Longitudinal Mucosal Incision During POEM PROCEDURE

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).

Longitudinal Mucosal Incision During POEM

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Nacional de Colombia: lead
• Hospital San Rafael de Facatativá: collaborator

Study Sites (1)

Alzate

Bogotá, Colombia

Location

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Juan P Alzate, MD, MsC

CONTACT

+573102587912; jpalzategr@unal.edu.co

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Operator blinding is not feasible due to the nature of the techniques. Participants will remain masked. The primary outcome time will be extracted objectively using automatic timestamps/logs and assessed by masked evaluators; statistical analyses will be performed using masked group labels (A/B). Individual unmasking will be limited to clinical circumstances requiring it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research institute investigator

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: February 22, 2026
• Primary Completion (Estimated): July 2, 2026
• Study Completion (Estimated): August 2, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)