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临床试验/NCT04794140
NCT04794140Unknown不适用

A Randomized Controlled, Blinded, Prospective Clinical Study Evaluating the Effect of Endoscopic Ultrasound-guided Fine-needle Biopsy With Different Number of Passes on the Success Rate of Primary Cell Culture of Pancreatic Cancer

The Third Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Differences in the success rate of culturing primary cells

研究概览

简要总结

The Aim of this study is to investigate the amount of tissue required for the successful culture of primary cells from human-derived pancreatic ductal adenocarcinoma which obtained by endoscopic ultrasound-guided fine-needle biopsy wet suction technique

详细描述

Pancreatic cancer is one of the malignant tumors with the highest mortality rate in the world, with a 5-year survival rate of only 7.2%-9%. Because some patients are resistant to multiple chemotherapy drugs, and there are differences in drug sensitivity between individuals, the current pancreatic ductal adenocarcinoma (PDAC) chemotherapy effect is not satisfactory. In order to improve the efficacy of chemotherapy and achieve precise treatment, it is important to establish an accurate and individualized PDAC research model.

Because most of patients with PDAC have developed to advanced stage at the time of diagnosis, it is not suitable for surgery. That limits our ability to obtain tumor cells seriously. With the development of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) technique, it can be used not only to diagnose diseases, but also to provide specimens for molecular analysis and create valuable preclinical disease research models, so as to guide the selection of the most appropriate individualized treatment. EUS-FNB can obtain lesions without any treatment. Therefore, the preclinical disease research model established by EUS-FNB is more representative of the original tumor.

However, compared with surgical specimens, the specimens obtained by EUS-FNB are smaller in size, which may affect the successful construction of research models in vitro. Therefore, the investigators plan to use EUS-FNB wet suction technique, a modified specimen acquisition method, to obtain PDAC tissue, and use it for primary cell culture, to explore the amount of tissue required for the successful cultivation of human-derived pancreatic cancer primary cells, so as to provide a prerequisite for the successful establishment of human-derived preclinical disease research model.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female, age≥18
  • Imaging examination (US, MRI, CT or PET-CT) of patients confirmed pancreatic lesions, and considered the possibility of PDAC, EUS-FNB was needed for auxiliary diagnosis
  • No chemotherapy, including neoadjuvant chemotherapy, postoperative adjuvant chemotherapy and palliative chemotherapy, has been performed on patients
  • Agree to attend this study and signed informed consent

排除标准

  • Poor physical condition, including but not limited to hemoglobin ≤ 8.0g/dl, severe cardiopulmonary insufficiency, etc
  • Coagulation dysfunction (platelet count < 50 × 1012, international standardized ratio > 1.5), or inability to discontinue anticoagulation therapy
  • High risk for deep sedation
  • Acute pancreatitis in the previous 2 weeks
  • Pregnancy or lactation
  • Any diseases leading to unreliable follow-up
  • Absence of informed consent

结局指标

主要结局

Differences in the success rate of culturing primary cells

时间窗: About 6 weeks after operation

Differences in the success rate of pancreatic cancer primary cells (P1) and culture to the third generation (P3) between the two groups.

The difference in the representation to the original tumor between the two groups of primary cells

时间窗: About 8 weeks after operation

Through Western Blot and PCR methods to detect the representativeness of primary cells to the primary tumor. If the patient underwent surgery later, hematoxylin-eosin staining and/or immunohistochemistry were added to compare the histological morphology with the original tumor.

次要结局

  • The relationship between the success rate of primary cell culture and some tumor characteristics(About 6 weeks after operation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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