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EUS-FNA With/Without MFB for Pancreatic Cysts

N/A

Recruiting

Led By Mihir Wagh, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-4 weeks

Awards & highlights

Study Summary

This trial is testing a new method for sampling pancreatic cysts to improve diagnosis. The new method uses a micro forceps through a needle to biopsy the cyst wall in addition to collecting cyst fluid.

Who is the study for?

This trial is for adults over 18 with pancreatic cysts larger than 20mm, suitable for needle aspiration based on symptoms, imaging, or patient concern. It's not for those with low platelets, bleeding risks, unsafe cyst characteristics via ultrasound, inability to consent, pregnancy or if surgery altered access to the cyst.Check my eligibility

What is being tested?

The study compares two methods of examining pancreatic cysts: one using only Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA), and another combining EUS-FNA with Micro Forceps Biopsies (MFB) to improve diagnosis and inform treatment decisions.See study design

What are the potential side effects?

Potential side effects may include discomfort at the biopsy site, minor bleeding or bruising from needle insertion. There's also a small risk of infection or pancreatitis after the procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intraprocedural

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intraprocedural

This trial's timeline: 3 weeks for screening, Varies for treatment, and intraprocedural for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.

Safety of EUS-FNA plus MFB with that of EUS-FNA by recording adverse events per published ASGE (American Society for Gastrointestinal Endoscopy) criteria.

Technical Success of EUS-FNA plus MFB, with EUS-FNA alone for evaluation of PCLs.

Secondary outcome measures

Technical ease in performing FNA and MFB

Time taken for FNA and time for MFB

Trial Design

2Treatment groups

Active Control

Group I: 1). EUS-FNA plus MFBActive Control1 Intervention

A 19-G needle plus micro-forceps will be used for FNA plus MFB.

Group II: 2). EUS-FNA AloneActive Control1 Intervention

A 19-G needle will be used for FNA alone.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

US EndoscopyIndustry Sponsor

3 Previous Clinical Trials

1,528 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,226 Total Patients Enrolled

Mihir Wagh, MDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

EUS-FNA Alone Clinical Trial Eligibility Overview. Trial Name: NCT04404101 — N/A

Pancreatic Cyst Research Study Groups: 1). EUS-FNA plus MFB, 2). EUS-FNA Alone

Pancreatic Cyst Clinical Trial 2023: EUS-FNA Alone Highlights & Side Effects. Trial Name: NCT04404101 — N/A

EUS-FNA Alone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04404101 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can potential participants currently join this investigation?

"According to the clinicaltrials.gov, this investigation is currently seeking participants, beginning from 5th November 2021 and updated as recently as 12th August 2021."

Answered by AI

For whom is this research experiment accessible?

"With the purpose of gathering data on pancreatic cyst, this medical study is seeking 300 individuals aged 18 to 89. To be eligible for participation, adults must meet all requirements including being over eighteen years old."

Answered by AI

What is the participant count of this research project?

"Affirmative. Clinicaltrials.gov attests that this research programme is actively trying to enlist participants, having initially been posted on May 11th 2021 and recently edited in December 8th 2021. 300 people are sought from 3 distinct medical centres."

Answered by AI

Is the age limit for acceptance into this trial restricted to those over 30 years old?

"To be eligible for this trial, applicants must fulfill the age requirement of 18 to 89. Additionally, there are 11 total trials available with 1 specifically targeting those under 18 and 10 suitable for patients over 65 years old."

Answered by AI

Recent research and studies

Digestive and Liver DiseaseJournal

European Experts Consensus Statement on Cystic Tumours of the Pancreas

Del Chiaro, Marco, Caroline Verbeke, Roberto Salvia, Gunter Klöppel, Jens Werner, Colin McKay, Helmut Friess, et al.. 2013. “European Experts Consensus Statement on Cystic Tumours of the Pancreas”. Digestive and Liver Disease. Elsevier BV. doi:10.1016/j.dld.2013.01.010.

GastroenterologyJournal

Diagnosis of Pancreatic Cystic Neoplasms: A Report of the Cooperative Pancreatic Cyst Study

Brugge, William R., Kent Lewandrowski, Elizabeth Lee-Lewandrowski, Barbara A. Centeno, Tara Szydlo, Susan Regan, Carlos Fernandez del Castillo, and Andrew L. Warshaw. 2004. “Diagnosis of Pancreatic Cystic Neoplasms: A Report of the Cooperative Pancreatic Cyst Study”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2004.02.013.

GastroenterologyJournal

American Gastroenterological Association Institute Guideline on the Diagnosis and Management of Asymptomatic Neoplastic Pancreatic Cysts

Vege, Santhi Swaroop, Barry Ziring, Rajeev Jain, Paul Moayyedi, Megan A. Adams, Spencer D. Dorn, Sharon L. Dudley-Brown, et al.. 2015. “American Gastroenterological Association Institute Guideline on the Diagnosis and Management of Asymptomatic Neoplastic Pancreatic Cysts”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2015.01.015.

PancreatologyJournal