EUS-guided FNB-induced PANCREatitis Assessment

NCT07168863 | Recruiting DMC

• 1 other identifier: IR.TUMS.DDRI.REC.1404.010
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatitis, Acute; EUS Guided Biopsy

Keywords

acute pancreatitis; EUS-guided FNB

Outcome Measures

Primary Outcomes (1)

• Incidence of Post-EUS-FNB acute pancreatitis

  Determining the incidence of acute pancreatitis after EUS-guided FNB from the pancreatobiliary lesions

  From enrollment to three days after EUS-FNB

Secondary Outcomes (2)

• Factors associated with post-EUS-FNB pancreatitis

  From enrollment to three days after EUS-FNB

• Incidence of moderate to severe post-FNB pancreatitis

  From enrollment to one week after EUS-FNB

Interventions

EUS-guided FNB DEVICE

EUS-guided FNB from the lesions in the pancreatobiliary tract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive inpatients and outpatients aged 18 years or older undergoing EUS-guided FNB at Shariati Hospital

You may qualify if:

• 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 may not qualify if:

• 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

Sponsors & Collaborators

• University of Tehran: lead

Study Sites (1)

Shariati Hospital, Digestive Diseases Research Institute

Tehran, Tehran Province, 1411713135, Iran

RECRUITING

Related Publications (2)

• Eloubeidi MA, Gress FG, Savides TJ, Wiersema MJ, Kochman ML, Ahmad NA, Ginsberg GG, Erickson RA, Dewitt J, Van Dam J, Nickl NJ, Levy MJ, Clain JE, Chak A, Sivak MV Jr, Wong R, Isenberg G, Scheiman JM, Bounds B, Kimmey MB, Saunders MD, Chang KJ, Sharma A, Nguyen P, Lee JG, Edmundowicz SA, Early D, Azar R, Etemad B, Chen YK, Waxman I, Shami V, Catalano MF, Wilcox CM. Acute pancreatitis after EUS-guided FNA of solid pancreatic masses: a pooled analysis from EUS centers in the United States. Gastrointest Endosc. 2004 Sep;60(3):385-9. doi: 10.1016/s0016-5107(04)01714-6.

  PMID: 15332028 BACKGROUND

• Magahis PT, Chhoda A, Berzin TM, Farrell JJ, Wright DN, Rizvi A, Hanscom M, Carr-Locke DL, Sampath K, Sharaiha RZ, Mahadev S. Risk of Pancreatitis After Endoscopic Ultrasound-Guided Fine-Needle Aspiration of Pancreatic Cystic Lesions: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2024 Nov 1;119(11):2174-2186. doi: 10.14309/ajg.0000000000002942. Epub 2024 Jul 5.

  PMID: 38976379 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Mehdi Mohamadnejad, MD

CONTACT

+982182415104; mehdi.nejad@gmail.com

Atieh Moghtadaie, MD

CONTACT

+982182415104; atiemoghtadaie@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 11, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): February 12, 2027
• Study Completion (Estimated): March 12, 2027
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: IPD will be accessible following the study's publication and will remain available for three years.
• Access Criteria: IPD will be shared for collaborative research after reviewing the requester's research protocol

Locations

IR (1)