Risk of pancreatitis after EUS-guided fine-needle biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.