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

Not yet recruiting
Conditions
Pancreatic Cyst Fluid
Registration Number
NCT05962723
Lead Sponsor
Asian Institute of Gastroenterology, India
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.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
sensitivity, specificity and accuracyOne Year

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

Secondary Outcome Measures
NameTimeMethod
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