An observational study in Pancreatic Cyst Fluid, sponsored by Asian Institute of Gastroenterology, India. Not yet recruiting. Open to participants aged 18 Minutes to 60 Years. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Asian Institute of Gastroenterology, India · Observational
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.
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.
97 studies on the registry are indexed under Pancreatic Cyst; 37 are open to participants now.
This study's planned enrollment of 30 is below the median of 300 across 55 observational studies indexed under Pancreatic Cyst.
Browse Pancreatic Cyst studies →Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.
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Participants with pancreatic cyst of size >2 cm, seen on radiological image, having no contraindication for endoscopic ultrasound and has not suffered from pancreatitis within last 3 months) coming to OPD/admitted in ward in AIG Hospital , Hyderabad satisfying inclusion and exclusion criteria after informed consent, will be included.
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Exclusion Criteria:
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.
sensitivity, specificity and accuracy
sensitivity, specificity and accuracy of pancreatic cystic fluid glucose level with comparison to fluid CEA levels, morey's biopsy result and surgical findings.
Time frame: One Year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2023; primary completion for Apr 2024, 8 months later.
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This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Asian Institute of Gastroenterology, India →