Набор по приглашению NCT05678491

Endoscopic Treatment of Gastroesophageal Reflux Disease

Без фазы С лечением Gastro Esophageal Reflux Disease

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: Endoscopic mucosal band ligation.
Кому может быть актуально: Состояния в реестре: Gastro Esophageal Reflux Disease. Базовые параметры: 18 лет — 70 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: Норвегия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus. This is a particular problem after surgery to reduce obesity called gastric sleeve resection. The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. The main questions it aims to answer are: * Does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal reflux * Does the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors) Participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of GERD. Suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. The effects will be assessed three and six months after the procedure.

Подробное описание

Gastroesophageal reflux disease (GERD) is very common after gastric sleeve resection and many patients are dependent on daily use of proton pump inhibitors (PPIs). The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation.

Patients (n=12) with GERD satisfying inclusion and exclusion criteria will be invited to participate and the degree of gastroesophageal reflux will be assessed before treatment, and three and six months after the procedure. The results of the trial will be used to plan a larger study.

Вмешательства

Другое Endoscopic mucosal band ligation
The mucosa in 3/4 of the circumference of the gastroesophageal junction and cardia will be treated with mucosal band ligation left in place. This will be done during upper endoscopy in sedation. It is the endoscopic procedure that is being investigated.

Первичные конечные точки

Change from baseline esophageal 24 hour pH/impedance at 3 months [Срок оценки: 3 months]
Change from baseline esophageal 24 hour pH/impedance at 6 months [Срок оценки: 6 months]
Change from baseline symptoms of gastroesophageal reflux at 3 months [Срок оценки: 3 months]
Change from baseline symptoms of gastroesophageal reflux at 6 months [Срок оценки: 6 months]
Change from baseline in use of proton pump inhibitors (PPI) at 3 months [Срок оценки: 3 months]
Change from baseline in use of proton pump inhibitors (PPI) at 6 months [Срок оценки: 6 months]
Adverse events during the study period of 6 months [Срок оценки: 6 months]

Вторичные конечные точки (4)

Change from baseline in dysphagia at 3 months [Срок оценки: 3 months]
Change from baseline in dysphagia at 6 months [Срок оценки: 6 months]
Change from baseline in Hills flap valve at 3 months [Срок оценки: 3 months]
Change from baseline in Hills flap valve at 6 months [Срок оценки: 6 months]

Критерии участия

Inclusion Criteria (all criteria must be fulfilled):

Previous gastric sleeve resection
GERD. GERD must be diagnosed by either endoscopic esophagitis or esophageal pH measurement with DeMeester score > 14.72 and pH <4 more than 4% of a 24-h period and symptom association probability (SAP) > 95%
Subjective insufficient symptom control with PPI therapy once daily or intolerance to PPI or desire to stop PPI treatment and therefore willingness to undergo endoscopic treatment.