A Pilot Study of the Effects of Contrast Enhanced Endoscopic Ultrasound on Determining Vascular Involvement in Pancreatic Lesions
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Lesion Margin
研究概览
简要总结
In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer requires surgical removal. Surgical removal of the pancreas is associated with high morbidity and mortality, as well as high rates of complications. One way to aid surgeons in removing pancreatic tumors is by providing them with a good idea of where the tumor is located and what surrounding structures are involved. This currently happens through many different modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound. Even with these forms of imaging (and sometimes others), surgeons will occasionally open a patient and find that the tumor cannot be removed due to its involvement with surrounding structures.
One way to avoid potentially unnecessary procedures or to help a surgeon navigate this delicate procedure would be to provide more detailed information about the tumor. Several of the techniques currently used to image the body have rapidly advanced over recent years. Typical advancements come through better resolution of the images or contrast to enhance desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound has seen substantial advances in resolution to enhance picture quality, but contrast has not been used clinically to assess pancreatic masses whereas it is for cardiologists to use contrast to look at potential defects in the heart.
The contrast that is used with ultrasound is different from that of CT scans. CT scanners use a dye that can be potentially hazardous. This dye can lead to serious kidney damage in some patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled with a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the sound waves differently than the surrounding tissue and thus provide contrast between normal tissue and abnormal tissue. The contrast used in this study, Definity, and is the same contrast used by Cardiologists.
The CE-EUS will be used for research purposes only and will not be used for any clinical decision making. The surgeon will be blinded to the results of the research CE-EUS. The investigators will compare the research pre-operative contrast enhanced endoscopic ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic involvement seen in surgery and the pathology reports.
详细描述
- CT Scan of the abdomen - Standard Therapy
a. The standard of care is that patients in question of pancreatic lesions undergo CT scanning. After a CT scan, if it appears that the pancreatic mass may be resectable, the standard protocol is to look at the pancreas while the patient is sedated with endoscopic ultrasound for diagnostic tissue sampling and further staging. For this reason, the endoscopist will not be blinded to the CT scan because it is the standard of care that they interpret the results of the EUS with that information. 2. Consent for Endoscopic Ultrasound (EUS) - Standard Therapy
a. Before being sedated and having endoscopic ultrasound, all patients are informed about the risks of the procedure, alternatives, and what will be done. The patients who decide to undergo endoscopic ultrasound will sign a consent form. Our goal is to enroll 30 patients (This number is limited by both the amount of contrast received from Lantheus and the number of patients typically seen in a year. Ideally we will enroll as many as possible for the purposes of power). 3. Consent for Contrast Enhanced Endoscopic Ultrasound (CE-EUS) -- Performed exclusively for research purposes
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After the patient has been informed about the standard of care and signed a consent form, the patient will be asked if they wish to participate in an experimental study. If the patient is interested, they will be questioned about potential structural heart defects, congenital heart defects, recent worsening of heart or lung conditions, pulmonary hypertension, potential pregnancy, attempts to become pregnant, if they are nursing, or allergies to the contrast. If they report any of these relative contraindications, we will exclude them from participating in the study.
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If they are free of all of those relative contraindications, they will be provided information about the study (see included forms) and will be asked to sign a consent form as well as a HIPAA authorization.
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EUS - Standard of Care
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At this point they will undergo an endoscopic ultrasound of the pancreas as per standard protocol. They will have a peripheral IV started by the endoscopic technician or nurse anesthetist. While the patient is being prepared, both research questionnaires (EUS and CE-EUS) will be filled out ahead of time with the exception of the findings, in order to reduce the time to complete the survey. The patient will be sedated in one of two ways. Either they will be consciously sedated with meperidine and midazolam under the surveillance of the attending gastroenterologist or they will have propofol based sedation under the surveillance of an anesthesiologist as per standard endoscopic ultrasound protocol.
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The patient will undergo their endoscopic ultrasound and video and images will be recorded.
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EUS Questionnaire - Preformed exclusively for research purposes. Duration less than one minute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with pancreatic lesion undergoing EUS for diagnosis and pre-operative assessment.
排除标准
- •Pregnant women, breastfeeding women and individuals with metastatic lesions on CT.
研究组 & 干预措施
Definity
Patients enrolled in the study will undergo contrast enhanced endoscopic ultrasound of the pancreas with Definity contrast after they have undergone their standard of care endoscopic ultrasound of the pancreas.
干预措施: Definity Contrast (Drug)
结局指标
主要结局
Lesion Margin
时间窗: Up to six months
次要结局
- Sequence of filling(Up to six months)
- Pattern of Perfusion(Up to six months)
- Degree of venous washout(Up to six months)
研究者
James Hebert
Mackay-Page Professor of Surgery
University of Vermont