Набор по приглашению NCT06567691

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Без фазы С лечением Malignant Gastric Outlet Obstruction

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: EUS Gastrojejunostomy, Surgical Gastrojejunostomy, Gastric Outlet Obstruction Scoring System (GOOSS).
Кому может быть актуально: Состояния в реестре: Malignant Gastric Outlet Obstruction. 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: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy for Treatment of Malignant Gastric Outlet Obstruction: a Randomized Controlled Trial

Обзор

Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterostomy should be the preferred endoscopic treatment approach. EUS gastroenterostomy and surgical gastrojejunostomy have been compared in retrospective cohort analysis, suggesting a high technical success rate a shorter hospital length of stay for the endoscopic approach \[4\]. Comparison of these techniques has not been reported in controlled prospective fashion. A prospective trial is necessary in order to define the optimal interventional management option for treatment of malignant GOO in the context of the contemporary and rapidly evolved range of available endoscopic and surgical treatment options.

Вмешательства

Процедура EUS Gastrojejunostomy
Endoscopic Ultrasound (EUS) Gastrojejunostomy. Under live real-time EUS visualization, a solution of normal saline or water and dilute methylene blue will be infused through the nasobiliary drainage catheter to mechanically distend the small intestine and create a suitable, expanded fluid-filled target for transgastric access. Once a suitable target has been identified, a lumen apposing metal stent (LAMS) will then be deployed securely across the newly created gastroenterostomy tract. Appropriat
Процедура Surgical Gastrojejunostomy
Gastrojejunostomy will be performed via an open technique using an upper midline or left sub-costal incision (at the discretion of the surgeon). An antecolic, pro-peristaltic, gastrojejunostomy will be performed using one of two standard techniques: 1) hand-sewn: 2-layer anastomosis using absorbable suture or 2) stapled: single-layer anastomosis using a surgical stapler with closed staple height ranging from 1.0 - 1.5 mm and suture closure of the common enterotomy. Feeding tube placement will be
Другое Gastric Outlet Obstruction Scoring System (GOOSS)
A previously validated instrument for assessing tolerance of oral intake.

Первичные конечные точки

Compare of restoration of oral intake following EUS versus surgical gastrojejunostomy [Срок оценки: 1 day post-operative]
Compare post procedure length of hospital stay [Срок оценки: 14 days post-operative]

Критерии участия

Критерии включения

Age 18 years or older
Able to provide informed consent
Biopsy-proven cancer
Cancer without surgical resection as a curative treatment option
Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum