An observational study in Pancreatitis, Acute and EUS Guided Biopsy, sponsored by University of Tehran. Recruiting at 1 site in Iran. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by University of Tehran · Observational
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.
EUS-guided tissue acquisition is an advanced diagnostic procedure for evaluating and diagnosing pancreatic, ampullary, and biliary tract tumors due to its high accuracy and minimally invasive nature. However, a potential complication is acute pancreatitis. This can lead to serious clinical problems, including severe abdominal pain, prolonged hospitalization, and, in rare cases, life-threatening complications. EUS-guided FNA of pancreatic masses is infrequently associated with acute pancreatitis. The incidence of pancreatitis after FNA of solid and cystic pancreatic lesions is reported to be 0.64%, and 1.4%, respectively (1, 2). The designs of the tips of FNA and FNB needles are different, and it may have impact on the risk of pancreatitis after FNB. Personal observations of the researchers of this study suggest that the risk of pancreatitis is likely higher after EUS-FNB than EUS-FNA, however, the incidence of pancreatitis after EUS-guided FNB is not systematically studied. The purpose of this study is to determine the incidence of acute pancreatitis after EUS-FNB and identify the risk factors associated with post-EUS-FNB pancreatitis to help prevent and manage this complication, improve clinical outcomes, reduce treatment costs, and enhance diagnostic accuracy for pancreatic and biliary tract diseases. The study is a descriptive analytical study that will be conducted on patients referred to the endoscopy department of Shariati Hospital in Tehran who will undergo EUS-guided FNB.
Patient information, including demographic data and clinical characteristics, will be collected using specialized checklists based on clinical interviews, patient examinations, and review of patient records. The data collected will include gender, age, indication for FNB, history of acute or chronic pancreatitis, and technical details of the procedure, such as the needle brand and size, anatomical location of the biopsy, amount of normal pancreatic tissue the needle passes through, number of passes, and the biopsy site (stomach or duodenum).
All patients meeting the inclusion criteria will be enrolled in the study. 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. Patients who develop pancreatitis will receive standard diagnostic and therapeutic follow-up. The study plans to enroll at least 300 patients.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 192 observational studies indexed under Pancreatitis.
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Consecutive inpatients and outpatients aged 18 years or older undergoing EUS-guided FNB at Shariati Hospital
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inpatients and outpatients aged 18 years or older undergoing EUS-guided FNB from a solid or cystic lesion in one of the following locations:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EUS-guided FNB from the lesions in the pancreatobiliary tract
Incidence of Post-EUS-FNB acute pancreatitis
Determining the incidence of acute pancreatitis after EUS-guided FNB from the pancreatobiliary lesions
Time frame: From enrollment to three days after EUS-FNB
Factors associated with post-EUS-FNB pancreatitis
The secondary objectives are to determine the role of the following factors in the development of pancreatitis after EUS-guided FNB: * Gender * Age * Biopsy site * Dilation of the main pancreatic duct (PD) and common bile duct (CBD) * The amount of normal pancreatic tissue the needle passes through * Number of needle passes * Number of back and forth movement of the needle in each pass * Biopsy approach (transgastric or transduodenal) * History of pancreatitis * Type of lesion (solid vs. cystic) * Needle size
Time frame: From enrollment to three days after EUS-FNB
Incidence of moderate to severe post-FNB pancreatitis
The incidence of moderate to severe post-FNB pancreatitis will be assessed using Atlanta classification.
Time frame: From enrollment to one week after EUS-FNB
Plan to share: Yes — IPD will be shared for collaborative research after reviewing the requester's research protocol
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, 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
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University of Tehran