An observational study in Pancreatic Carcinoma, Pancreatic Neuroendocrine Tumor and Autoimmune Pancreatitis, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by Peking Union Medical College Hospital · Observational
Study objective: To describe the microflora characteristics of the pancreatic solid lesions via the tissue acquired via the endoscopic ultrasound-guided fine needle aspiration/biopsy (EUS-FNA/B).
Study design: This is a prospective observational study.
This is a prospective observational study. Patients who need EUS-FNA/B for diagnosis of pancreatic solid lesions (pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis, etc)will be successively included in this study. The EUS-FNA/B procedures will be accomplished in the standard way after the puncture site is washed with 20ml sterile saline for three times. The remaining fresh tissue after sufficient specimen collected for the diagnosis will be stored in - 80℃ fridge. DNA is extracted from all samples using the suitable kit and V4 16S rRNA gene sequencing is performed on all samples. The investigators ran "Decontam" (Davis NM, et al. Microbiome 2018;6:226) in order to identify and remove contaminant DNA sequences from the dataset. And the microbiome is analyzed with the standard methodology. The investigators tend to describe the microflora characteristics of pancreatic solid lesions and try to compare the differences between cancer and benign diseases.
This study will carry out in two stages: the preliminary stage, 10 patients will be included. If the technic success rate (successful extraction of DNA and sequencing of 16s rRNA after bioinformatical removal of potential DNA contaminations via the use of 'Decontam') is high than 50%, the successive inclusion progress [the main stage] will last for one year.
676 studies on the registry are indexed under Neuroendocrine Tumors; 169 are open to participants now.
This study's enrollment of 200 is above the median of 115 across 176 observational studies indexed under Neuroendocrine Tumors.
Browse Neuroendocrine Tumors studies →Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.
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Patients who need EUS-FNA/B for diagnosis of pancreatic solid lesions.
Exclusion Criteria:
Microflora analysis accomplished
successful extraction of DNA and sequencing of 16s rRNA after bioinformatical removal of potential DNA contaminations via the use of 'Decontam', and microflora result is obtained.
Time frame: within one month after EUS-FNA/B procedure
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital