Actively Recruiting

Age: 18Years +
All Genders
ID07168863

Incidence and Risk Factors of Acute Pancreatitis Following Endoscopic Ultrasound-Guided Fine Needle Biopsy (EUS-FNB)

Led by University of Tehran · Updated on 2025-09-15

300

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how often acute pancreatitis occurs after Endoscopic Ultrasonography-guided Fine Needle Biopsy (EUS-FNB) in patients with pancreatic and biliary tract diseases. This observational study aims to identify risk factors for pancreatitis following EUS-FNB to improve clinical care, reduce complications, lower treatment costs, and enhance diagnostic accuracy. The study will focus on patients treated at Shariati Hospital in Tehran, assessing post-procedure outcomes to provide better management of pancreatic and biliary diseases. The study involves collecting demographic and clinical data from patients undergoing EUS-guided FNB on lesions in the pancreas, ampulla of Vater, or distal common bile duct. Amylase and lipase blood levels will be tested 24 hours after the procedure to help diagnose pancreatitis, which is identified based on abdominal pain and enzyme levels three times above the normal range. An expert gastroenterologist not involved in the biopsies will review medical records to confirm cases, using consensus guidelines but applying clinical judgment when needed. Patients will be followed up by phone 24 to 72 hours after the procedure to monitor complications. Participants will undergo clinical interviews, examinations, and record reviews to gather information such as age, gender, biopsy details, and history of pancreatitis. Outcomes include measuring the incidence of pancreatitis up to three days post-biopsy and assessing associated risk factors. Those who develop pancreatitis will receive standard care and follow-up. The study plans to enroll at least 300 patients, with monitoring continuing up to one week for moderate to severe pancreatitis cases.

CONDITIONS

Brief Title

EUS-guided FNB-induced PANCREatitis Assessment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Undergoing EUS-guided fine needle biopsy from a solid or cystic lesion in the pancreas, ampulla of Vater, or distal common bile duct
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Undergoing concurrent ERCP on the same day as EUS-FNB
  • Experiencing an ongoing episode of acute pancreatitis during EUS-FNB
  • Undergoing EUS-guided fine needle aspiration (FNA) instead of FNB
  • Having uncorrectable bleeding disorders (INR > 1.5 or platelet count < 50,000)
  • Declining to participate or not signing informed consent
  • Undergoing EUS-guided FNB from the proximal common bile duct where the needle does not pass through the pancreas

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of procedure

Participants undergo EUS-guided fine needle biopsy (FNB) from lesions in the pancreatobiliary tract.

1 visit (in-person)

Monitoring

Duration - Up to 1 week

Participants are monitored for complications such as acute pancreatitis and related symptoms for up to one week after the procedure.

1 to 2 follow-up contacts within 24 to 72 hours post-procedure

Trial Site Locations

Total: 1 location

1

Shariati Hospital, Digestive Diseases Research Institute

Tehran, Tehran Province, Iran, 1411713135

Actively Recruiting

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Research Team

M

Mehdi Mohamadnejad, MD

A

Atieh Moghtadaie, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Acute pancreatitis after EUS-guided FNA of solid pancreatic masses: a pooled analysis from EUS centers in the United States.

Mohamad A Eloubeidi, Frank G Gress, Thomas J Savides...

https://pubmed.ncbi.nlm.nih.gov/15332028

Risk of Pancreatitis After Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions: A Systematic Review and Meta-Analysis.

Patrick T Magahis, Ankit Chhoda, Tyler M Berzin...

https://pubmed.ncbi.nlm.nih.gov/38976379