Pancreatic Cyst Fluid Glucose: New Armamentarium in the Diagnosis of Mucinous Pancreatic Cystic Lesion (CYST FLUID 01)

January 2, 2024 updated by: Asian Institute of Gastroenterology, India

Primary objectives

• To check for sensitivity and specificity of cystic fluid glucose level for differentiating the mucinous & non mucinous pancreatic cyst

Secondary Objectives:

  • comparison of cystic fluid tumor makers like CEA with cystic fluid glucose level.
  • Check for cutoff value of cystic fluid glucose level for diagnosis of mucinous pancreatic cyst in Indian population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

For patients who have a pancreatic cyst bigger than 2cm found during a radiology exam, they will undergo an Endoscopic ultrasound exam to check the cyst and fluid will be collected for testing, including glucose, CEA (carcinoembryonic antigen), and amylase. A biopsy will be done if possible. We will analyze how well the glucose level in the fluid can tell us if the cyst is cancerous or not, using CEA level, EUS findings, and amylase level as the standard. This is an observational study, and patients will receive standard medical treatment. The study won't change the treatment they receive.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Sample size of 30. Participants: 30 (15 mucinous & 15 non mucinous) Participants will be recruited over a period of 1 year (2023 - 2024).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mucinous (malignant)
For patients who have a pancreatic cyst bigger than 2cm found during a radiology exam, they will undergo an Endoscopic ultrasound exam to check the cyst and fluid will be collected for testing, including glucose, CEA (carcinoembryonic antigen), and amylase. A biopsy will be done if possible. We will analyze how well the glucose level in the fluid can tell us if the cyst is cancerous or not, using CEA level, EUS findings, and amylase level as the standard. This is an observational study, and patients will receive standard medical treatment
Diagnostic test: non-cancerous cyst
For patients who have a pancreatic cyst bigger than 2cm found during a radiology exam, they will undergo an Endoscopic ultrasound exam to check the cyst and fluid will be collected for testing, including glucose, CEA (carcinoembryonic antigen), and amylase. A biopsy will be done if possible. We will analyze how well the glucose level in the fluid can tell us if the cyst is cancerous or not, using CEA level, EUS findings, and amylase level as the standard. This is an observational study, and patients will receive standard medical treatment.
non mucinous (Non-malignant) pancreatic cyst.
For patients who have a pancreatic cyst bigger than 2cm found during a radiology exam, they will undergo an Endoscopic ultrasound exam to check the cyst and fluid will be collected for testing, including glucose, CEA (carcinoembryonic antigen), and amylase. A biopsy will be done if possible. We will analyze how well the glucose level in the fluid can tell us if the cyst is cancerous or not, using CEA level, EUS findings, and amylase level as the standard. This is an observational study, and patients will receive standard medical treatment
Diagnostic test: cancerous cyst.
For patients who have a pancreatic cyst bigger than 2cm found during a radiology exam, they will undergo an Endoscopic ultrasound exam to check the cyst and fluid will be collected for testing, including glucose, CEA (carcinoembryonic antigen), and amylase. A biopsy will be done if possible. We will analyze how well the glucose level in the fluid can tell us if the cyst is cancerous or not, using CEA level, EUS findings, and amylase level as the standard. This is an observational study, and patients will receive standard medical treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• To check for sensitivity and specificity of cystic fluid glucose level for differentiating the mucinous & non mucinous pancreatic cyst
Time Frame: 1 YEAR(2023-2024)
Primary outcome will be measured in terms of sensitivity, specificity and accuracy of pancreatic cystic fluid glucose level with comparison to fluid CEA levels, morey's biopsy result and surgical findings by Gold standard test
1 YEAR(2023-2024)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison of cystic fluid tumor makers like CEA with cystic fluid glucose level.
Time Frame: 1 YEAR (2023-2024)
comparison of cystic fluid tumor makers like CEA with cystic fluid glucose leveL by Gold standard test
1 YEAR (2023-2024)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asian Institute of Gastroenterology, India

Investigators

  • Principal Investigator: Mona Aggarwal, AIG Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 24, 2024

Primary Completion (Estimated)

December 5, 2025

Study Completion (Estimated)

December 20, 2025

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Estimated)

January 3, 2024

Study Record Updates

Last Update Posted (Estimated)

January 3, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • : pancreatic cyst glucose 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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