Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions

Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions and Study of Its Application for Diagnosis, Treatment and Prognosis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05497271

Enrollment

500

Registered

2022-08-11

Start date

2017-01-01

Completion date

2025-12-31

Last updated

2022-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Molecular, Chemical Analysis of Cystic Fluid, Pancreatic Cyst

Brief summary

Through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. patients who diagnosed with pancreatic cystic lesion 2. patients who are able to acquire cystic fluid through EUS-FNA or surgery 3. patients aged 18 years and older

Exclusion criteria

1. patients who did not want to participate in this study 2. patients aged under 18 years old 3. severely mentally ill patients 4. pregnant women

Design outcomes

Primary

Measure	Time frame	Description
diagnostic accuracy by cystic fluid analysis	up to 5 years after cystic fluid analysis	diagnostic accuracy by cystic fluid analysis in comparison with pathologic diagnosis

Secondary

Measure	Time frame	Description
Disease free survival	up to 5 years after cystic fluid analysis or surgical resection	Period till tumor recurrence after surgical resection or intervention
Malignant transformation rate	up to 5 years after cystic fluid analysis	the prevalence of malignant transformation during follow-up period (percent)
Prediction for treatment response in case of surgical resected or EUS-guided ethanol ablated pancreatic cysts	up to 5 years after cystic fluid analysis or EUS guided ablative therapy	evaluation of treatment response for surgery of EUS guided therapy according to RECIST criteria v1.1
Cytology of cystic fluid	within 2 months after study enrollment	result of cytology of cystic fluid
Overall survival	up to 5 years after cystic fluid analysis or surgical resection	overall survival until death
Chemical profile of Amylase in cystic fluid	within 2 months after study enrollment	level of amylase in cystic fluid
Chemical profile of glucose in cystic fluid	within 2 months after study enrollment	level of glucose in cystic fluid
DNA mutation profile of cystic fluid	within 2 months after study enrollment	targeted NGS for KRAS, NRAS, CDKN2A, TP53, SMAD4, RNF43, PTEN, PIK3CA, VHL, Aneuploid
Chemical profile of CEA in cystic fluid	within 2 months after study enrollment	level of CEA in cystic fluid

Countries

South Korea

Outcome results