Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04536220

Establish Diagnostic Models Based on Portal Venous Blood for Pancreatic Cancer

Explore new markers based on portal venous blood sampling to establish novel diagnostic models for identification of malignant pancreatic mass.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Kaixuan Wang, MD

CONTACT

[email protected]

86-21-31161353

About this study

EUS-FNA combined cytology detection is an important method for clinical diagnosis of squamous cell carcinoma. However, due to factors such as sampling method, smear making, staining technique, lower levels of the pathologists and other factors, its diagnostic sensitivity is still not very satisfactory. Poor diagnostic efficacy usually means another puncture, longer hospital stay, more medications and a higher incidence of adverse events. Missed diagnosis continuously directly delays the treatment time of the disease and seriously affects the patient's prognosis. Therefore, how to use new technologies to improve the differential diagnosis efficiency of benign and malignant pancreatic occupants is the key to improving the prognosis of diabetic cancer patients.

The portal vein blood comes from the venous tract, including the blood flowing from the plasma to the liver. By collecting blood samples from the patient's portal vein, clinicians can separate more information from the patient. Studies have shown that the portal vein blood can be collected by ultrasound endoscopic puncture. This method is less traumatic, convenient and safe, and more information about the retinal tissue can be obtained. It is an important way to improve the efficiency of patient diagnosis. This study intends to use ultrasound endoscopic puncture technology to obtain portal vein blood, and use big data and ctDNA, metabolomics, exosomes and other different omics methods to screen the potential value of volume-occupying benign and malignant differential diagnosis markers in portal vein blood. Peripheral blood will simultaneously be collected to evaluate the efficacy of these newly developed markers.

Who can participate

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

Inclusion criteria

  • age 18-75 years,male or female
  • diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)
  • lesion diameter larger than 1 cm
  • signed informed consent letter

Exclusion criteria

  • pregnant female
  • Pancreatic cystic lesions
  • Anticoagulant/antiplatelet therapy cannot be suspended
  • unable or refuse to provide informed consent
  • Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)
  • Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
  • with history of mental disease
  • other medical conditions that are not suitable for EUS-FNA

Treatment and study plan

Endoscopic Ultrasound (EUS), Fine Needle Aspiration

Diagnostic Test

Endoscopic Ultrasound (EUS), Fine Needle Aspiration, which are routine clinical operations

Primary outcomes

  1. Status of survival

    Time frame: through study completion, an average of 1 year

    To varify if the patients died becaused of malignant pancreatic cancer.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangyu Kong, MD

CONTACT

[email protected]

13564644397

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Establish a Diagnostic Model Based on Multiple Molecule Profiling and Certain Established Markers for Identification of Pancreatic Cancer

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2020
Registry last updated
Mar 29, 2024

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.