Skip to main content
OpenTrials
Completed

NCT Number: NCT05171517

Study on Microflora Characteristics of Pancreatic Solid Lesions Via Endoscopic Ultrasound-guided Fine Needle Aspiration/Biopsy

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.

Completed

Looking for future studies?

Notify Me

Key information

About this 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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Microflora analysis accomplished

    Time frame: within one month after EUS-FNA/B procedure

    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.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 29, 2021
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.