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UnknownNCT05962723

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

Status
Unknown
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Asian Institute of Gastroenterology, India · Academic / Other
Sex
All
Age
18 Minutes – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEUSEUS 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.

Timeline

Start date
2023-08-20
Primary completion
2024-04-20
Completion
2024-04-20
First posted
2023-07-27
Last updated
2023-07-27

Source: ClinicalTrials.gov record NCT05962723. Inclusion in this directory is not an endorsement.