An interventional study of different number of passes in Pancreatic Ductal Adenocarcinoma, sponsored by The Third Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by The Third Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
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
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.
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This study's planned enrollment of 60 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
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We use the endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique to procure the specimens, and use the sample obtained from a single pass for primary cell culture. EUS-FNB wet suction technique refer from Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.
Procedure: different number of passes
We use the endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique to procure the specimens, and use the sample obtained from two passes for primary cell culture. EUS-FNB wet suction technique refer from Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.
Procedure: different number of passes
Each patient's operation process is the same, that is, after obtaining enough specimens for diagnosis by endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique, additional three passes are performed. One of which is randomly selected as the one pass group, and the other two passes automatically as the two pass group. Please refer to the literature for EUS-FNB wet technique (Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.)
Differences in the success rate of culturing primary cells
Differences in the success rate of pancreatic cancer primary cells (P1) and culture to the third generation (P3) between the two groups.
Time frame: About 6 weeks after operation
The difference in the representation to the original tumor between the two groups of primary cells
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.
Time frame: About 8 weeks after operation
The relationship between the success rate of primary cell culture and some tumor characteristics
Statistical methods such as chi-square test are used to analyze whether the success rate of primary cell culture is related to the tumor size, degree of differentiation, clinical stage, and the length of macroscopic visible core tissue.
Time frame: About 6 weeks after operation
Plan to share: No
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The Third Xiangya Hospital of Central South University