Transverse vs Longitudinal Mucosal Incision During POEM

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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).
• Процедура 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).

Первичные конечные точки

• Time to Effective Submucosal Tunnel Entry (Seconds) [Срок оценки: During the POEM procedure (Day 0; intraoperative)]

Вторичные конечные точки (2)

• Bleeding Requiring Hemostasis With Coagrasper® [Срок оценки: During the POEM procedure (Day 0; intraoperative)]
• Procedure-Related Complications (Up to 30 Days) [Срок оценки: Up to 30 days after the procedure (contacts at ~1 week and Day 30; plus early assessment Days 1-2).]

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Колумбия · 1 центр

• Alzate — Bogotá

Идентификаторы

NCT: NCT07425977 · DE-F-254-V8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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