Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions

Pancreatic Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497271
• Other study ID #: H-2206-213-1336
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cyst

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	overall survival until death	up to 5 years after cystic fluid analysis or surgical resection
Secondary	Disease free survival	Period till tumor recurrence after surgical resection or intervention	up to 5 years after cystic fluid analysis or surgical resection
Secondary	Malignant transformation rate	the prevalence of malignant transformation during follow-up period (percent)	up to 5 years after cystic fluid analysis
Secondary	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
Secondary	Cytology of cystic fluid	result of cytology of cystic fluid	within 2 months after study enrollment
Secondary	Chemical profile of CEA in cystic fluid	level of CEA in cystic fluid	within 2 months after study enrollment
Secondary	Chemical profile of Amylase in cystic fluid	level of amylase in cystic fluid	within 2 months after study enrollment
Secondary	Chemical profile of glucose in cystic fluid	level of glucose in cystic fluid	within 2 months after study enrollment
Secondary	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