A Phase 3 interventional study of Transverse Mucosal Incision During POEM and Longitudinal Mucosal Incision During POEM in Esophageal Achalasia and Spastic Esophageal Motility Disorders, sponsored by Universidad Nacional de Colombia. Not yet recruiting at 1 site in Colombia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Universidad Nacional de Colombia · Phase 3, Interventional, and Treatment
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.
143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's planned enrollment of 140 is above the median of 56 across 95 interventional studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Universidad Nacional de Colombia is the lead sponsor of 39 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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).
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).
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.
Time frame: During the POEM procedure (Day 0; intraoperative)
Bleeding Requiring Hemostasis With Coagrasper®
Proportion of procedures with bleeding that requires hemostasis using Coagrasper® (Yes/No).
Time frame: During the POEM procedure (Day 0; intraoperative)
Procedure-Related Complications (Up to 30 Days)
Any complication related to the procedure, monitored through 30 days.
Time frame: Up to 30 days after the procedure (contacts at ~1 week and Day 30; plus early assessment Days 1-2).
Plan to share: No
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Universidad Nacional de Colombia