NCT02921100

Brief Summary

150 patients who had suspected pancreatic malignancy were planed to be enrolled in this study. Equal cytological samples of each patient undergoing EUS-FNA were examined by digital image analysis and conventional cytology respectively. The investigators aim to compare the efficacy of DIA and conventional cytology in diagnosing pancreatic cancer. Further more, the investigators also collected the blood sample of each enrolled patient for advanced study.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Last Updated

September 30, 2016

Status Verified

September 1, 2016

Enrollment Period

1.8 years

First QC Date

September 26, 2016

Last Update Submit

September 29, 2016

Conditions

Biopsy, Fine-Needle

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with accurate diagnosis by conventional cytology versus by DNA ploidy test

    12 months

Secondary Outcomes (4)

  • sensitivity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy

    12 months

  • specificity of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy

    12 months

  • positive predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy

    12 months

  • negative predictive value of conventional cytology Versus DNA ploidy test in the diagnosis of pancreatic malignancy

    12 months

Study Arms (2)

Conventional cytology

OTHER

Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo a conventional cytology.

Procedure: cytologyProcedure: EUS-FNADevice: EUS-guided fine needle

DNA ploidy test

OTHER

Patients in this arm will undergo an operation of EUS-FNA . The acquired cytological samples from EUS-FNA will undergo DNA ploidy test.

Procedure: DNA ploidyProcedure: EUS-FNADevice: EUS-guided fine needle

Interventions

cytologyPROCEDURE

The conventional cytology was interpreted independently by two cytopathologists, both of whom are blinded to the DIA results. The conventional cytologic diagnosis were classified as no abnormal cells, atypical cells, suspicious malignant cells and malignant cells.

Conventional cytology
DNA ploidyPROCEDURE

DIA is a form of cytologic analysis that quantifies cellular constituents by using spectro photometric principles and a sister technique to flow cytometry.Quantification of DNA content, chromatin distribution, and nuclear morphology can be determined and suggest features of malignancy

Also known as: digital image analysis
DNA ploidy test
EUS-FNAPROCEDURE

All the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step.

Conventional cytologyDNA ploidy test
EUS-guided fine needleDEVICE
Conventional cytologyDNA ploidy test

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • who had known or suspected pancreatic malignancy and
  • in whom the endosonographer deemed the target lesion safe and feasible to allow the necessary study passes.

You may not qualify if:

  • not willing to sign informed consent,
  • cells obtained from FNA for DNA ploidy test less than 200, and/or
  • patients do not cooperate with follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Interventions

Cytological TechniquesPloidiesEndoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic PhenomenaBiopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Dong Wang, Dr.

    Digestive endoscopic center of Changhai Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of gastroenterology department

Study Record Dates

First Submitted

September 26, 2016

First Posted

September 30, 2016

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Last Updated

September 30, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)