Идёт набор NCT06613945

ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

Без фазы С лечением Malignant Hilar Stricture

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: ERCP biliary drainage, Combined ERCP and EUS-HGS biliary drainage.
Кому может быть актуально: Состояния в реестре: Malignant Hilar Stricture. 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: Египет
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 Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction

Обзор

A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals

Подробное описание

Bilateral stenting by Endoscopic Retrograde Cholangiopancreatography in malignant hilar biliary obstructions (MHBO) is challenging and technically difficult. EUS hepaticogastrostomy (EUS-HGS) has been increasingly used as an alternative method to achieve internal biliary drainage in MHBO. Because of the difficulty of ERCP in such scenario, the combination of EUS-HGS and ERCP provides a possible chance of longer stent patency with less event of stent clogging Aim of the work: to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced MHBO.

The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 1:1 ratio to: ERCP biliary drainage (ERCP-BD) group: bilateral metallic stents insertion will be attempted by transpapilary approach. Combined ERCP and EUS-HGS group: unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS.

technical success, clinical success, procedural duration, and re-interventions and adverse events will be assesed

Вмешательства

Процедура ERCP biliary drainage
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
Процедура Combined ERCP and EUS-HGS biliary drainage
unilateral metallic stent will be inserted on right side by ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage.

Первичные конечные точки

Technical success [Срок оценки: during the procedure]
Procedural duration [Срок оценки: at the end of the procedure]
Clinical success [Срок оценки: 3 month]
Re-interventions [Срок оценки: 3 month]

Вторичные конечные точки (1)

Adverse events [Срок оценки: 3 month]

Критерии участия

Критерии включения

Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III \& IV only.
Histologically confirmed malignant hilar biliary obstruction.
Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
Absence of duodenal narrowing/obstruction.
Accept sharing in the study