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Идёт набор NCT03221335

EUS-guided RFA for Solid Abdominal Neoplasms

Без фазы С лечением Digestive System Neoplasms

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-guided RFA.
Кому может быть актуально
Состояния в реестре: Digestive System Neoplasms. 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
Гонконг
Следующий шаг
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Официальное название

Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Abdominal Neoplasms.

Обзор

Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of solid abdominal neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic cancers. The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid abdominal neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid abdominal neoplasms.

Подробное описание

RFA causes tissue destruction through the application of a high frequency alternating current, generating local temperatures above 60°C and leading to coagulative necrosis. The technique has been widely used in many solid organ tumours and has been shown to result in 5-year survival rates comparable to surgery. The technique is currently the standard therapy in hepatocellular carcinoma and colorectal pulmonary metastasis particular in patients that are not suitable for surgery.

The current study would be a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from solid neoplasms of the liver, stomach and adrenals would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a VIVA RF generator (STARmed, Korea). The primary outcome would be the overall adverse events rate. Secondary outcomes include mortality, technical success rate, completion ablation rate, 1 \& 3 year overall and disease-free survival.

Вмешательства

  • Устройство EUS-guided RFA
    All patients would undergo EUS with a linear array echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue. The duration of ablation would be according to the size of the lesion.

Первичные конечные точки

  • Severe adverse events [Срок оценки: 30 days]
Вторичные конечные точки (6)
  • Technical success rates [Срок оценки: 1 week]
  • Procedural times [Срок оценки: 1 day]
  • Hospital stay [Срок оценки: 30 days]
  • Radiological response [Срок оценки: 1 year]
  • Number of re-interventions [Срок оценки: 1 year]
  • Survival [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Age 18 years-old or above
  • Suffering from solid neoplasms of the stomach, liver, kidney or adrenals (<5cm in largest diameter) that is indicated for treatment.
  • Unsuitable for surgery, due to one (or more) of the following items:
  • ASA score > II\*
  • An alternative advanced malignancy
  • Unsuitable for surgery upon expert's opinion for any other reason
  • Healthy individuals who are not keen for surgical resection
  • Eligible for endoscopic intervention
  • Written informed consent

Критерии исключения

  • Coagulopathy (international normalized ratio >1.3, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL
  • Pregnancy
  • Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study
  • Patients unwilling to undergo follow-up assessments
  • Patients with liver cirrhosis, portal hypertension and/or gastric varices.

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

Гонконг · 1 центр
  • Department of Surgery, Prince of Wales Hospital — Гонконг

Идентификаторы

NCT: NCT03221335 · CRE-2015.707

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗