Actively Recruiting
EUS-guided FNB-induced PANCREatitis Assessment
Led by University of Tehran · Updated on 2025-09-15
300
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a descriptive analytical study to investigate the prevalence and risk factors for pancreatitis after Endoscopic Ultrasonography-guided Fine Needle Biopsy (EUS-FNB) in patients at Shariati Hospital in Tehran. The study aims to identify risk factors for post-FNB pancreatitis to improve clinical protocols, reduce complications and treatment costs, and increase diagnostic accuracy for pancreatic and biliary tract diseases. The study will collect demographic and clinical data from all eligible patients undergoing EUS-guided FNB during the study period. Amylase and lipase levels will be measured in all enrolled patients 24 hours post-procedure. Pancreatitis will be diagnosed based on abdominal pain and amylase or lipase levels exceeding three times the normal range 24 hours after the procedure. The outcomes will be independently adjudicated by an expert gastroenterologist not involved in the EUS procedures by reviewing participants' medical records. The consensus definition will be applied as a diagnostic framework (rather than a strict definition) so that the adjudicator can use their best judgment in cases that does not strictly satisfy the criteria. The patients will be contacted 24-72 h after the procedure to follow-up on any potential complications. The study plans to enroll at least 300 patients.
CONDITIONS
Official Title
EUS-guided FNB-induced PANCREatitis Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
Inpatients and outpatients aged 18 years or older undergoing EUS-guided FNB from a solid or cystic lesion in one of the following locations:
- Pancreas
- Ampulla of Vater
- Distal CBD, defined as the intrapancreatic portion of the CBD where the FNB needle passes through the pancreas during biopsy
You will not qualify if you...
- Patients who undergo concurrent ERCP in the same day
- Patients experiencing an ongoing episode of acute pancreatitis during EUS-FNB
- Patients undergoing EUS-guided FNA
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Decline to participate in the study and sign the informed consent form
- Patients undergoing EUS-guided FNB from the proximal CBD where the FNB needle does not traverse the pancreas
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shariati Hospital, Digestive Diseases Research Institute
Tehran, Tehran Province, Iran, 1411713135
Actively Recruiting
Research Team
M
Mehdi Mohamadnejad, MD
CONTACT
A
Atieh Moghtadaie, MD
CONTACT
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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