Risk of pancreatitis after EUS-guided fine-needle biopsy
Incidence and Risk Factors of Acute Pancreatitis Following EUS-Guided Fine Needle Biopsy (EUS-FNB)
This project will see how often adults who have EUS-guided fine-needle biopsy of pancreatic, ampullary, or intrapancreatic bile duct lesions develop pancreatitis and which factors increase that risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Tehran Academic / other |
| Locations | 1 site (Tehran, Tehran Province) |
| Trial ID | NCT07168863 on ClinicalTrials.gov |
What this trial studies
This observational, descriptive-analytical study will enroll adults undergoing EUS-guided FNB at Shariati Hospital in Tehran and collect demographic and clinical data. Serum amylase and lipase will be measured 24 hours after the procedure and pancreatitis will be defined by abdominal pain plus enzyme levels greater than three times the normal range. The study will analyze patient and procedure-related factors to identify associations with post-FNB pancreatitis. All outcomes will be independently adjudicated by an expert gastroenterologist not involved in the procedures.
Who should consider this trial
Good fit: Adults (≥18) scheduled for EUS-guided FNB of the pancreas, ampulla of Vater, or intrapancreatic common bile duct who can give informed consent and do not have active acute pancreatitis or uncorrectable clotting/platelet disorders.
Not a fit: Patients undergoing same-day ERCP, those having EUS-guided FNA instead of FNB, patients with an ongoing episode of acute pancreatitis during the procedure, or those with uncorrectable coagulopathy or thrombocytopenia are excluded and will not benefit directly from this study.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify high-risk patients, adjust biopsy practices, and reduce post-procedure pancreatitis, hospital stays, and costs.
How similar studies have performed: Prior work reports low pancreatitis rates after EUS-FNA, but the incidence and risk factors after newer FNB needles have not been systematically studied, making this a relatively novel focused analysis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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
Where this trial is running
Tehran, Tehran Province
- Shariati Hospital, Digestive Diseases Research Institute — Tehran, Tehran Province, Iran (Recruiting)
Study contacts
- Study coordinator: Mehdi Mohamadnejad, MD
- Email: mehdi.nejad@gmail.com
- Phone: +982182415104
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.