Clinical Evaluation Of NCLE in The Lymph Nodes Along With Masses and Cystic Tumors of the Pancreas
试验速览
- 阶段
- 不适用
- 入组人数
- 330
- 试验地点
- 6
- 主要终点
- Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes
研究概览
简要总结
This study focuses on three different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract and pancreatic masses.
On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses and Lymph nodes are less developed.
The study therefore comprises two sub-studies, one on the pancreatic cysts, and another on pancreatic masses and lymph nodes.
- Cysts The primary hypothesis of the study is that using nCLE in addition to EUS-FNA and tissue sampling allows better characterization of pancreatic cysts and improves appropriate therapeutic decision-making.
For physicians, integrating nCLE into the diagnostic algorithm of pancreatic cysts could impact patient management by :
- Ruling out malignancy for patients with benign appearing nCLE images.
- Characterizing more malignant tumors in the pancreas.
- Pancreatic masses and Lymph nodes The primary hypothesis of the study is that in vivo imaging of lymph-nodes near the gastrointestinal tract and pancreatic masses during EUS-FNA procedures is feasible and that descriptive criteria can be defined to further differentiate the different types of lesions.
详细描述
- Medical background Pancreatic cancer is the fourth leading cause of cancer-related death in the United States. This disease is associated with a high mortality rate: the 5-year survival rate is estimated to be 4%. This is mainly due to the fact that the disease is often discovered at an already advanced disease state, which carries a dismal prognosis.
1.1. Pancreatic Cysts
Pancreatic cysts are quite rare, but are being increasingly recognized due to the expanding use of cross-sectional imaging. They are classified into three main classes:
- Pseudocysts
- Serous cysts : either serous cystic neoplasms (SCN) or Solid pseudo-papillary neoplasm (SPN)
- Mucinous cystic neoplasms : either Intraductal Papillary Mucinous Neoplasm (IPMN) or mucinous cystadenomas/mucinous cystadenocarcinoma(MCN) Mucinous cystic neoplasms are considered to be malignant or pre-malignant and are considered for surgical resection, whereas pseudocysts and serous cysts are considered benign and with a low potential for malignancy. Pseudocysts and serous cysts are usually only considered for surgical resection when symptomatic or enlarging.
1.2. Pancreatic masses Pancreatic solid masses can be either exocrine or endocrine tumors, or metastatic.Exocrine tumors are by far the most common type of pancreas cancer. Most of them are malignant. About 96% of cancers of the exocrine pancreas are adenocarcinomas, which is the most aggressive form of pancreas cancer.Endocrine tumors are uncommon. They represent 4% of pancreas tumors. They are known as neuroendocrine tumors (NETs), or islet cell tumors. These tumors can be benign or malignant.
1.3. Lymph nodes Lymph nodes are examined in a patient with a suspicion of, or confirmed, cancer, as part of the staging. They may be either normal, inflammatory, or malignant. 2. Clinical background
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
- •Male or female > 18 years of age.
- •Patient indicated for a first EUS-FNA for a pancreatic cyst, lymph node or pancreatic mass, or
- •Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for pancreatic cyst, lymph nodes, pancreatic mass, more than three months ago.
- •Patient with known pancreatic cyst or mass detected at cross-sectional imaging or suspicious lymph nodes reachable via EUSFNA
- •Willing and able to comply with study procedures and provide written informed consent to participate in the study.
- •Add for lymph nodes:
- •any lymph node reachable with EUS-FNA
- •Add for pancreatic mass:
- •any location in the pancreas
排除标准
- •Subjects for whom EUS-FNA procedures are contraindicated
- •Known allergy to fluorescein dye
- •If female, pregnant based on a positive hCG serum or an in vitro diagnostic test result or breast-feeding
- •Add for cysts:
- •Subject with multiple cysts
- •size < 20mm in diameter
- •previous EUS-FNA procedure performed less than 3 months ago - Patients suffering chronic calcifying pancreatitis
- •Add for lymph nodes:
- •size < 5mm in diameter
- •If patients present several suspicious lymph nodes, only one of them will be imaged during the nCLE procedure
- •Add for pancreatic mass:
- •If patient present several pancreatic masses, only one of them will be imaged during the nCLE procedure
研究组 & 干预措施
Lymph nodes, pancreatic masses & cysts
干预措施: EUS-FNA (Procedure)
Lymph nodes, pancreatic masses & cysts
干预措施: nCLE (Device)
结局指标
主要结局
Descriptive criteria in nCLE sequences for the characterization of pancreatic masses and lymph nodes
时间窗: Within one year after the end of the follow-up period
Diagnostic performance of the Cellvizio nCLE system in the characterization of pancreatic cysts
时间窗: Within 6 months after the end of Follow-up period
次要结局
- Atlas of images of nCLE sequences of pancreatic masses and lymph nodes during EUS-FNA(within 3 months of the end of the follow-up period)
- Impact of the Cellvizio nCLE system on the management of a patient with pancreatic cyst(Within one year after the end of the follow-up period)
- Diagnostic performance of nCLE in the diagnosis of pancreatic masses and lymph nodes, when associated with other diagnostic information(within one year after the end of the follow-up period)
- Feasibility and safety data on nCLE during EUS-FNA procedure(Within 3 months after the end of the enrollment period)
- Validation of the interpretation criteria classification for pancreatic cysts(within 6 months after the end of the follow-up period)