Идёт набор NCT06816615

Diagnosis and Percutaneous Treatment of Biliary Tract Diseases

Без фазы С лечением Gallstone Biliary Stricture Biliary Diseases

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: Percutaneous cholangioscopic-assisted treatment.
Кому может быть актуально: Состояния в реестре: Gallstone, Biliary Stricture, Biliary Diseases. 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: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to implement and optimize the treatment of bile duct diseases in participants not eligible for endoscopic treatment using the Spyglass system, a system suitable for diagnostic and therapeutic endoscopic procedures in the pancreatic-biliary system, including the hepatic ducts. The main question it aims to answer is: \- Can the percutaneous cholangioscopic assisted technique resolve the biliary litiasis and/or perform endobiliary biopsies in less time than the traditional technique? Participants will undergo a colangioscopic-assisted treatment using the SpyGlass mini-endoscopic system at the Addomino-pelvic diagnostic and interventional radiology UOC of the Bologna University Hospital.

Подробное описание

This is a pilot, spontaneous, non-pharmacological, prospective and single-center interventional study aimed at participants with bile duct diseases not eligible for endoscopic treatment, who, once enrolled, will undergo percutaneous colangioscopic-assisted treatment at the Addominal-pelvic diagnostic and interventional radiology UOC of the University Hospital of Bologna. After a 24-month enrollment phase, a 36-month follow-up phase will be undertaken to assess the functional and therapeutic outcomes of this approach.

The enrollment and the collection of informed consent will be carried out by the Radiologists involved in the study who will also take care of the collection of clinical data and the review of all pseudoanymous radiological images pre/post treatment in order to evaluate the outcome of percutaneous treatment, the number of treatments, the duration of drainage stay, the relapse-free interval and the length of hospitalization. Participants in the study will undergo treatments commonly used in daily clinical practice, including biliary clearance and/or endobiliary biopsy.

Вмешательства

Процедура Percutaneous cholangioscopic-assisted treatment
The intervention administered is a percutaneous colangioscopic assisted technique that uses endoscopic Spyglass system. The endoscopic Spyglass system is designed to provide direct viewing and to guide both optical devices and accessories for lithotripsy in case of litiasic pathology and is equipped with a suitable bioptic clamp in case of biopsy collection. The use of the digital Spyglass catheter involves the preliminary percutaneous puncture of the bile ducts with a right, left or combined ap

Первичные конечные точки

Number of treatments [Срок оценки: From enrollment to the end of treatment at 7 years]
Duration of drainage [Срок оценки: From enrollment to the end of treatment at 7 years]
Relapse free interval [Срок оценки: From enrollment to the end of treatment at 7 years]
Duration of hospitalization [Срок оценки: From enrollment to the end of treatment at 7 years]

Критерии участия

Критерии включения

Radiological diagnosis of indeterminate gallstones or stenosis of the bile ducts not eligible for endoscopic treatment and/or previous failed endoscopic treatment
Good liver function (hemoglobin, hematocrit, GOT, GPT, GGT within normal ranges)
Age over 18
Obtaining informed consent