Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions

Seoul National University Hospital500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Pancreatic Cyst Molecular, Chemical Analysis of Cystic Fluid

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

diagnostic accuracy by cystic fluid analysis

diagnostic accuracy by cystic fluid analysis in comparison with pathologic diagnosis

Time frame: up to 5 years after cystic fluid analysis

Secondary Outcomes

Overall survival

overall survival until death

Time frame: up to 5 years after cystic fluid analysis or surgical resection

Disease free survival

Period till tumor recurrence after surgical resection or intervention

Time frame: up to 5 years after cystic fluid analysis or surgical resection

Malignant transformation rate

the prevalence of malignant transformation during follow-up period (percent)

Time frame: up to 5 years after cystic fluid analysis

Prediction for treatment response in case of surgical resected or EUS-guided ethanol ablated pancreatic cysts

evaluation of treatment response for surgery of EUS guided therapy according to RECIST criteria v1.1

Time frame: up to 5 years after cystic fluid analysis or EUS guided ablative therapy

Cytology of cystic fluid

result of cytology of cystic fluid

Time frame: within 2 months after study enrollment

Chemical profile of CEA in cystic fluid

level of CEA in cystic fluid

Time frame: within 2 months after study enrollment

Chemical profile of Amylase in cystic fluid

Data from ClinicalTrials.gov

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