Clinical trial NCT05171517: Study on Microflora Characteristics of Pancreatic Solid Lesions Via Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy
Official title: Study on Microflora Characteristics of Pancreatic Solid Lesions Via Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Carcinoma
Pancreatic Neuroendocrine Tumor
Autoimmune Pancreatitis
Microflora
Keywords: pancreatic solid lesion
microflora
fine needle aspiration/biopsy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who need EUS-FNA/B for diagnosis of pancreatic solid lesions.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients who need EUS-FNA/B for diagnosis of pancreatic solid lesions.
* Age ≥ 18 years and \< 80 years.

Exclusion Criteria:

* Including but not limited to: poor general conditions, severe cardiopulmonary disease, difficult to tolerate EUS examination; coagulation dysfunction; platelets \<50×10\^9/L

Primary outcomes:
measure: Microflora analysis accomplished
timeFrame: within one month after EUS-FNA/B procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Aiming Yang, M.D.
role: STUDY_DIRECTOR
References: