Набор скоро начнётся NCT07115420

Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Ducts: Comparing Two Types of Endoscopically Placed Internal Stents to Prevent Blockage of a Lumen Apposing Metal Stent

Без фазы С лечением Malignant Biliary Obstruction Advanced Pancreatic Cancer and Cholangiocarcinoma Inoperable Malignant Biliary Obstruction Lumen Apposing Metal Stents

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: Fully covered self expanding metal stent (FCSEMS) within LAMS, Double pigtail stent (DPS) within LAMS.
Кому может быть актуально: Состояния в реестре: Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma, Inoperable Malignant Biliary Obstruction, Lumen Apposing Metal Stents. 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: Новая Зеландия
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

Optimising EUS-guided Choledochoduodenostomy With Lumen Apposing Metal Stent With Stent in Stent Placement: a Randomised Study Between Double Pigtail Stent and Fully Covered Self-Expanding Metal Stent. The Opti-LAMS Study

Обзор

This study looks at the best way to treat bile duct blockage in people with advanced cancer that cannot be removed by surgery. A blocked bile duct can cause serious symptoms like yellowing of the skin (jaundice), infection, and pain. A common procedure called ERCP sometimes doesn't work in these patients. A newer method called EUS-guided choledochoduodenostomy (EUS-CDS) uses internal ultrasound to place a special metal tube (called a LAMS) to allow bile to drain. However, over time this stent can still become blocked. To reduce this risk, doctors can place a second stent inside the first. This study is comparing two types of these second stents: * A plastic stent (double pigtail stent or DPS) * A metal stent (fully covered self-expanding metal stent or FCSEMS) The study will include patients at Waikato Hospital. After the first stent is placed, they will be randomly assigned to receive either a DPS or FCSEMS. Patients will be followed for 6 months to see how well the stents work. The aim is to find out which approach keeps the bile duct open longer and reduces the need for further procedures or hospitalisation, helping improve care and comfort for people with advanced cancer

Вмешательства

Устройство Fully covered self expanding metal stent (FCSEMS) within LAMS
In those randomised to FCSEMS, size will depend on the size of the LAMS with a 6mm LAMS to be stented with 8mm diameter FCSEMS and an 8mm LAMS to be stented with a 10mm FCSEMS, 4cm or 6cm length. The aim is to have at least 3cm of FCSEMS in the duodenal lumen If unable to place FCSEM through LAMS, crossover to DPS is allowed with plan for both intention to treat and per protocol analysis to be undertaken after completion of the study
Устройство Double pigtail stent (DPS) within LAMS
In those randomised to DPS, a double pigtail will be placed through the LAMS. The size of the stents will be left to the discretion of the proceduralist though 7Fr calibre with 7cm length is the recommended size

Первичные конечные точки

To compare the incidence of stent dysfunction (defined as recurrent jaundice and/or cholangitis) in patients with malignant biliary obstruction receiving FCSEMS vs DPS stent-in-stent through LAMS [Срок оценки: 26 weeks]

Вторичные конечные точки (4)

Technical success of LAMS placement. [Срок оценки: 1 day]
Technical success of second stent-in-stent placement [Срок оценки: 1 day]
Clinical success of biliary drainage (evaluated at weeks 1, 2, 4, 12, and 26 using bilirubin and liver enzymes). [Срок оценки: weeks 1, 2, 4, 12, and 26]
Re-intervention rate [Срок оценки: 26 weeks]

Критерии участия

Критерии включения

Age ≥18 years.
Radiologically or histologically proven malignant distal bile duct obstruction with unresectable or metastatic disease, including those who have already failed ERCP
Indication for biliary drainage with presence of obstructive jaundice biochemically and dilated biliary system on imaging.
Informed consent provided.
Common bile duct (CBD) size of at least 12mm on EUS imaging