Pancreatitis, AcuteEUS-PANCREANCT07168863
EUS-guided FNB-induced PANCREatitis Assessment
An observational study of Pancreatitis, Acute and EUS Guided Biopsy, run by University of Tehran at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Acute, EUS Guided Biopsy
- What is being tested?
- EUS-guided FNB
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteIran
- Study dates
- 11 Sep 2025to 12 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive inpatients and outpatients aged 18 years or older undergoing EUS-guided FNB at Shariati Hospital
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Shariati Hospital, Digestive Diseases Research Institute
Tehran, Tehran Province, 1411713135
Atieh Moghtadaie, MD, +982182415104, atiemoghtadaie@gmail.com
About this study
Official title: Incidence and Risk Factors of Acute Pancreatitis Following EUS-Guided Fine Needle Biopsy (EUS-FNB)
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.
Read the detailed description
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.
- Conditions
- Pancreatitis, Acute, EUS Guided Biopsy
- Being tested
- EUS-guided FNB
- Keywords
- acute pancreatitis, EUS-guided FNB
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided FNBDevice
EUS-guided FNB from the lesions in the pancreatobiliary tract
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-EUS-FNB acute pancreatitis
Determining the incidence of acute pancreatitis after EUS-guided FNB from the pancreatobiliary lesions
Measured: From enrollment to three days after EUS-FNB
Secondary outcomes (2)
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
Measured: 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.
Measured: From enrollment to one week after EUS-FNB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start11 Sep 2025
- Primary completion12 Feb 2027 (estimated)
- Study completion12 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehdi Mohamadnejad, University of Tehran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168863
- Sponsor's protocol ID
- IR.TUMS.DDRI.REC.1404.010
- Acronym
- EUS-PANCREA
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared for collaborative research after reviewing the requester's research protocol
Publications
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.
PubMed 15332028Magahis 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.
PubMed 38976379
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Acute Pancreatitis Following EUS-Guided Fine Needle Biopsy (EUS-FNB)
- ClinicalTrials.gov ID
- NCT07168863
- Acronym / sponsor ID
- EUS-PANCREA / IR.TUMS.DDRI.REC.1404.010
- Conditions
- Pancreatitis, Acute, EUS Guided Biopsy
- Keywords
- acute pancreatitis, EUS-guided FNB
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 12 Feb 2027 (estimated)
- Study completion
- 12 Mar 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive inpatients and outpatients aged 18 years or older undergoing EUS-guided FNB at Shariati Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS-guided FNBEUS-guided FNB from the lesions in the pancreatobiliary tract | Device | – |
Primary outcome
Incidence of Post-EUS-FNB acute pancreatitis
Time frame: From enrollment to three days after EUS-FNB
Determining the incidence of acute pancreatitis after EUS-guided FNB from the pancreatobiliary lesions
2 secondary outcomes
Factors associated with post-EUS-FNB pancreatitis
Time frame: From enrollment to three days after EUS-FNB
Incidence of moderate to severe post-FNB pancreatitis
Time frame: From enrollment to one week after EUS-FNB
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Background: PubMed 15332028Eloubeidi 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.
- Background: PubMed 38976379Magahis 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.
- Individual participant dataSharing planned: Yes. IPD will be shared for collaborative research after reviewing the requester's research protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatitis, Acute and EUS Guided Biopsy, run by University of Tehran at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehdi Mohamadnejad, MD (+982182415104, mehdi.nejad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-EUS-FNB acute pancreatitis (time frame: From enrollment to three days after EUS-FNB). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07168863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.