Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Официальное название

Electromagnetic Positioning-Assisted Ultrasound Guidance in Transjugular Intrahepatic Portosystemic Shunt (TIPS): A Prospective, Single-Arm Study

Обзор

Transjugular intrahepatic portosystemic shunt (TIPS) is an important method for treating complications related to portal hypertension. The difficulty of its surgical procedures lies in portal vein puncture. Improper operation may lead to complications such as hepatic artery hemorrhage, hepatic capsular hemorrhage, and biliary tract hemorrhage. At present, the means of guiding portal vein puncture are limited. There is evidence supporting that ultrasound guidance can help reduce the number of punctures and lower the radiation dose, etc. However, ordinary ultrasound is limited by the influence of dimensions and can only guide punctures in the same plane, with limited guiding value. The use of the Imedis9000 magnetic navigation system can guide percutaneous vascular puncture in multiple dimensions, which can increase the success rate of puncture and shorten the operation time. This study conducted a prospective, single-arm study. The Imedis9000 magnetic navigation system was used for real-time positioning to guide precise TIPS stent implantation. The number of punctures, puncture success rate, stent implantation success rate, and the incidence of adverse events were evaluated to determine the application value of the Imedis9000 magnetic navigation system in TIPS procedure.

Вмешательства

• Другое ultrasound combined with electromagnetic positioning guidance
  TIPS procedure under ultrasound combined with electromagnetic positioning guidance

Первичные конечные точки

• Success rate of portal vein puncture [Срок оценки: During TIPS procedure]

Критерии участия

Критерии включения

• Age≥18 years old;
• Including but not limited to patients requiring TIPS for: acute esophageal/gastric variceal bleeding, portal hypertensive gastropathy, cirrhotic ascites, cirrhotic hydrothorax, hepatorenal syndrome, Budd-Chiari syndrome, atypical portal hypertension, portal vein thrombosis, prevention of recurrent esophageal/gastric variceal bleeding, or prevention of recurrent ectopic variceal bleeding;
• Deemed by clinicians to require Transjugular Intrahepatic Portosystemic Shunt (TIPS)
• Voluntarily signed informed consent form

Критерии исключения

• Severe right heart failure, congestive heart failure (ejection fraction <40%), or severe valvular heart disease;
• Persistent severe pulmonary hypertension (mean pulmonary artery pressure >45 mmHg) despite treatment;
• Uncontrolled systemic infection or inflammation;
• Hepatic encephalopathy stage III-IV;
• Presence of cardiac pacemaker, metallic implants, or other conditions susceptible to electromagnetic interference;
• Pregnancy or lactation;
• Poor visualization of the portal venous system on ultrasound;
• Investigator-determined unsuitability for study participation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06979622 · NFEC-2025-136

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗