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

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 Overview

• Status: Recruiting
• Conditions: Pancreatic Cyst; Molecular, Chemical Analysis of Cystic Fluid

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 101
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sang Hyub Lee, MD PhD; Phone Number: 01087036267; Email: gidoctor@snu.ac.kr
    • Principal Investigator: Sang Hyub Lee, MD PhD
    • Sub-Investigator: Jin Ho Choi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who were diagnosed with pancreatic cystic lesions and managed in Seoul National University Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	overall survival until death	up to 5 years after cystic fluid analysis or surgical resection
Disease free survival	Period till tumor recurrence after surgical resection or intervention	up to 5 years after cystic fluid analysis or surgical resection
Malignant transformation rate	the prevalence of malignant transformation during follow-up period (percent)	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	up to 5 years after cystic fluid analysis or EUS guided ablative therapy
Cytology of cystic fluid	result of cytology of cystic fluid	within 2 months after study enrollment
Chemical profile of CEA in cystic fluid	level of CEA in cystic fluid	within 2 months after study enrollment
Chemical profile of Amylase in cystic fluid	level of amylase in cystic fluid	within 2 months after study enrollment
Chemical profile of glucose in cystic fluid	level of glucose in cystic fluid	within 2 months after study enrollment
DNA mutation profile of cystic fluid	targeted NGS for KRAS, NRAS, CDKN2A, TP53, SMAD4, RNF43, PTEN, PIK3CA, VHL, Aneuploid	within 2 months after study enrollment

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (Actual): August 11, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 10, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Cysts; Pancreatic Diseases; Pancreatic Cyst
• Other Study ID Numbers: H-2206-213-1336

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No