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Pancreatic Cyst Fluid Glucose: New Armamentarium in the Diagnosis of Mucinous Pancreatic Cystic Lesion

Pancreatic Cyst Fluid Glucose: New Armamentarium in the Diagnosis of Mucinous Pancreatic Cystic Lesion

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05962723
Enrollment
30
Registered
2023-07-27
Start date
2023-08-20
Completion date
2024-04-20
Last updated
2023-07-27

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

Conditions

Pancreatic Cyst Fluid

Brief summary

All participants undergoing radiological imaging and found to have pancreatic cyst of size \> 2cm will be subjected to EUS (Endoscopic ultrasound) examination and cystic fluid will be aspirated for analysis, including cystic fluid Glucose, CEA, amylase. Morey's biopsy will be done in the cases feasible for biopsy. The sensitivity and specificity of cystic fluid glucose level will be analysed taking CEA (carcinoembryonic antigen) level with EUS findings, amylase level as gold standard for diagnosis, in cases with no surgical management.

Detailed description

Pancreatic cystic lesion prevalence noted to be increased dramatically in last few decades. Earlier record showed the prevalence rate of 2.4-2.6% with magnetic resonance imaging (MRI), though sometimes reaching 13.5%.Recent study showed prevalence of pancreatic cysts to be 49%. Most of the pancreatic cyst are benign and require conservative management and regular evaluation only. Malignant cystic lesion on the other hand require immediate attention and surgical excision in most of cases. Thus, diagnosis of pre-malignant & malignant pancreatic cyst are essential, to predict the prognosis and decide further management. Most widely accepted biochemical test for preoperative differentiation of mucinous from benign pancreatic cysts is cystic fluid carcinoembryonic antigen (CEA). CEA with cutoff value of 192 ng/ml has sensitivity, specifivcity and accuracy of 75%, 84% & 79% respectively. This is expensive and requires a longer duration for obtaining the results. Few recent studies proposed the role of cystic fluid glucose level in the diagnosis of malignant cyst.

Interventions

PROCEDUREEUS

EUS examination and cystic fluid will be aspirated for analysis, including cystic fluid Glucose, CEA, amylase. Morey's biopsy will be done in the cases feasible for biopsy.

Sponsors

Asian Institute of Gastroenterology, India
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Minutes to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients (between 18 to 60 years of age) * Pancreatic cyst of size \>2 cm noted on radiological imaging

Exclusion criteria

* Patient's age \<16yrs or \>80 yrs. * Prior history of pancreatitis (within 3 months) * Pregnant female * Unfit for endoscopic ultrasound * Not wiling for consent

Design outcomes

Primary

MeasureTime frameDescription
sensitivity, specificity and accuracyOne Yearsensitivity, specificity and accuracy of pancreatic cystic fluid glucose level with comparison to fluid CEA levels, morey's biopsy result and surgical findings.

Contacts

Primary ContactMona Aggarwal, MD, DM
drmona.11191@gmail.com8851352374

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026