Меню
Набор скоро начнётся NCT06872255

Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia

Без фазы С лечением Dysphagia Dysphagia, Esophageal Healthy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Per Oral Endoscopic Myotomy (POEM).
Кому может быть актуально
Состояния в реестре: Dysphagia, Dysphagia, Esophageal, Healthy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Чехия, Словакия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)

Обзор

Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.

Вмешательства

  • Процедура Per Oral Endoscopic Myotomy (POEM)
    All procedures will be performed by an experienced endoscopist, with a sufficient experience in "third space" endoscopy (at least 100 POEMs) under general anesthesia (internal preoperative examination is necessary) with a high-definition endoscope, fitted with a plastic distal attachment. Before the procedure, the patients will be administered intravenous antibiotics. Exclusively CO2 will be used for insufflation. POEM will be performed in a similar way as in patients with achalasia - the proced

Первичные конечные точки

  • Efficacy and safety of POEM in patients with postfundoplication dysfagia [Срок оценки: 6 months]
Вторичные конечные точки (11)
  • Eckardt score [Срок оценки: At baseline and after 3, 6 and 12 months]
  • Mellow - Pinkas score [Срок оценки: At baseline and after 3, 6 and 12 months]
  • PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life) [Срок оценки: At baseline and after 3, 6 and 12 months]
  • GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life) [Срок оценки: At baseline and after 3, 6 and 12 months]
  • Integrated Relaxation Pressure (IRP) [Срок оценки: At baseline and after 6 months]
  • Endoluminal planimetry (Endoflip) [Срок оценки: At baseline and after 6 months]
  • Esophagogram [Срок оценки: At baseline and after 6 months]
  • Eckardt score [Срок оценки: At and after 3 and 12 months]
  • GERD [Срок оценки: At baseline and after 3, 6 and 12 months]
  • Esophageal 24h-Hour pH metry [Срок оценки: At 3 months after procedure]
  • PPI/H2 antagonists [Срок оценки: At baseline and after 3, 6 and 12 months]

Критерии участия

Критерии включения

  • Patients after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.
  • Refractory (> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.
  • X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial/total stagnation of the contrast solution above the GEJ
  • Endoluminal planimetry: EGJ-DI < 3 mm2/mmHg (with 40ml)
  • Age above 18 years
  • Signed informed consent form

Критерии исключения

  • No previous attempt with at least one prokinetic drug
  • Previous esophageal myotomy (open, laparoscopic or endoscopic)
  • Primary esophageal motility disorder (achalasia etc.)
  • Active erosive esophagitis
  • Active peptic ulcer disease
  • Esophageal stricture (peptic, malignant, other)
  • Partial or complete supradiaphragmatic migration of the wrap and/or stomach (Hinder Type III - IV), Large hiatal hernia more than 5 cm
  • Known eosinophilic esophagitis
  • Severe coagulopathy
  • Esophageal or gastric varices
  • Advanced liver cirrhosis (Child B or Child C)
  • Pregnancy or puerperium
  • Malignant or pre-malignant esophageal diseases (dysplasia): patients with a history of such disease after its cure are eligible for enrolment
  • Any other condition, which in the opinion of the investigator would interfere with study requirements
  • Known gastroparesis

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Чехия · 1 центр
  • St. Anne's University Hospital Brno, Czech Republic — Brno
Словакия · 1 центр
  • University Hospital Trnava — Trnava

Идентификаторы

NCT: NCT06872255 · VADYSMA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗