EUS-guided RFA for Pancreatic Neoplasms

Официальное название

Multi-center Prospective Study on EUS-guided Radiofrequency Ablation for Solid Pancreatic 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 pancreatic 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 neoplasms. The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic 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 tumors 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.

This study is a multi-center prospective study involving four high volume international institutions. Consecutive patients suffering from pancreatic neuroendocrine tumors and pancreatic cancers would be recruited. EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator. 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

• Процедура EUS-guided RFA
  EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator

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 pancreatic neuroendocrine tumor or pancreatic ductal carcinoma (<5cm in largest diameter) that was confirmed by fine needle aspiration cytology
• 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: Да

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: NCT03218345 · CRE-2015.531T

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗