Establish Diagnostic Models Based on Portal Venous Blood for Pancreatic Cancer

NCT ID: NCT04536220

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-07-30

Brief Summary

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

Detailed Description

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.

Conditions

Diagnoses Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

pancreatic mass diagnosed benign

Through pathological examination, radiological examination and follow-up, these patients are finally diagnosed with benign pancreatic mass.

Endoscopic Ultrasound (EUS), Fine Needle Aspiration

Intervention Type: DIAGNOSTIC_TEST

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

pancreatic mass diagnosed malignant

Through pathological examination, radiological examination and follow-up, these patients are finally diagnosed with pancreaitic cancer.

Endoscopic Ultrasound (EUS), Fine Needle Aspiration

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Endoscopic Ultrasound (EUS), Fine Needle Aspiration

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. age 18-75 years,male or female

2. diagnosis or suspection of solid pancreatic mass based on previous imaging examination (ultrasonography, CT or MRI)

3. lesion diameter larger than 1 cm

4. signed informed consent letter

Exclusion Criteria

1. pregnant female

2. Pancreatic cystic lesions

3. Anticoagulant/antiplatelet therapy cannot be suspended

4. unable or refuse to provide informed consent

5. Coagulopathy (platelet count < 50× 103/μL,international normalized ratio > 1.5)

6. Severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia

7. with history of mental disease

8. other medical conditions that are not suitable for EUS-FNA

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhaoshen Li

Prefessor of Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kaixuan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangyu Kong, MD

Role: CONTACT

xiangyukong185@hotmail.com

13564644397

Facility Contacts

Kaixuan Wang, MD

Role: primary

wangkaixuan224007@sina.com

86-21-31161353

Other Identifiers

EMPVC

Identifier Type: -

Identifier Source: org_study_id