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RecruitingNCT05497271Updated Aug 12, 2022

Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions

An observational study in Pancreatic Cyst and Molecular, Chemical Analysis of Cystic Fluid, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-12.

Sponsored by Seoul National University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2017; still recruiting 9 years 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatic Cyst
  • Molecular, Chemical Analysis of Cystic Fluid

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03

In context

Pancreatic Cyst

94 studies on the registry are indexed under Pancreatic Cyst; 34 are open to participants now.

This study's planned enrollment of 500 is above the median of 300 across 50 observational studies indexed under Pancreatic Cyst.

Browse Pancreatic Cyst studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. 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

  1. Overall survival

    overall survival until death

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

  2. 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

  3. Malignant transformation rate

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

    Time frame: up to 5 years after cystic fluid analysis

  4. 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

  5. Cytology of cystic fluid

    result of cytology of cystic fluid

    Time frame: within 2 months after study enrollment

  6. Chemical profile of CEA in cystic fluid

    level of CEA in cystic fluid

    Time frame: within 2 months after study enrollment

  7. Chemical profile of Amylase in cystic fluid

    level of amylase in cystic fluid

    Time frame: within 2 months after study enrollment

  8. Chemical profile of glucose in cystic fluid

    level of glucose in cystic fluid

    Time frame: within 2 months after study enrollment

  9. DNA mutation profile of cystic fluid

    targeted NGS for KRAS, NRAS, CDKN2A, TP53, SMAD4, RNF43, PTEN, PIK3CA, VHL, Aneuploid

    Time frame: within 2 months after study enrollment

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 101, Korea, Republic of
    • Sang Hyub Lee, MD PhD · Contact · gidoctor@snu.ac.kr · 01087036267
    • Sang Hyub Lee, MD PhD · Principal investigator
    • Jin Ho Choi, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05497271
Lead sponsor
Seoul National University Hospital
Responsible party
Sang Hyub Lee (Professor, Seoul National University Hospital) — Principal investigator
First posted
Aug 11, 2022
Start date
Jan 1, 2017
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 12, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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