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

Sponsor

Asian Institute of Gastroenterology, India (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05962723

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cyst Fluid	Procedure: EUS

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 20, 2023

Anticipated Primary Completion Date :

Apr 20, 2024

Anticipated Study Completion Date :

Apr 20, 2024

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Minutes to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Asian Institute of Gastroenterology, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asian Institute of Gastroenterology, India

ClinicalTrials.gov Identifier:

NCT05962723

Other Study ID Numbers:

Pancreatic cyst glucose 1

First Posted:

Jul 27, 2023

Last Update Posted:

Jul 27, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cysts

Pancreatic Cyst

Study Results

No Results Posted as of Jul 27, 2023