NCT07168863 EUS-guided FNB-induced PANCREatitis Assessment
| NCT ID | NCT07168863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Tehran |
| Condition | Pancreatitis, Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-11 |
| Primary Completion | 2027-02-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-09-11 with a primary completion date of 2027-02-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07168863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatitis, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07168863 currently recruiting?
Yes, NCT07168863 is actively recruiting participants. Contact the research team at mehdi.nejad@gmail.com for enrollment information.
Where is the NCT07168863 trial being conducted?
This trial is being conducted at Tehran, Iran.
Who is sponsoring the NCT07168863 clinical trial?
NCT07168863 is sponsored by University of Tehran. The trial plans to enroll 300 participants.