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

NCT05962723 | Unknown

• 1 other identifier: Pancreatic cyst glucose 1
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cyst Fluid

Outcome Measures

Primary Outcomes (1)

• 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.

  One Year

Interventions

EUS PROCEDURE

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.

Eligibility Criteria

• Age: 18 Minutes - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients (between 18 to 60 years of age)
• Pancreatic cyst of size \>2 cm noted on radiological imaging

You may not qualify if:

• Patient's age \<16yrs or \>80 yrs.
• Prior history of pancreatitis (within 3 months)
• Pregnant female
• Unfit for endoscopic ultrasound
• Not wiling for consent

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Biospecimen

Retention: SAMPLES WITH DNA

cystic fluid glucose level

Central Study Contacts

Mona Aggarwal, MD, DM

CONTACT

8851352374; drmona.11191@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: August 20, 2023
• Primary Completion: April 20, 2024
• Study Completion: April 20, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share