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Trial Title:
Pancreatic Cyst Fluid Glucose: New Armamentarium in the Diagnosis of Mucinous Pancreatic Cystic Lesion
NCT ID:
NCT05962723
Condition:
Pancreatic Cyst Fluid
Conditions: Official terms:
Cysts
Pancreatic Cyst
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
EUS
Description:
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.
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Minutes
Maximum age:
60 Years
Healthy volunteers:
No
Start date:
August 20, 2023
Completion date:
April 20, 2024
Lead sponsor:
Agency:
Asian Institute of Gastroenterology, India
Agency class:
Other
Source:
Asian Institute of Gastroenterology, India
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05962723
