Pancreatitis, Pancreatitis Acute Biliary, Pancreatitis Biliary, Post-ERCP Acute Pancreatitis, Post-ERCP Adverse Events, Post-ERCP Pancreatitis
Conditions
Keywords
ERCP, pancreatitis, post-ERCP pancreatitis, PEP, pancreatitis acute biliary, post-ERCP adverse events
Brief summary
This study is a randomized clinical trial evaluating the efficacy of rectal indomethacin in preventing post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis in patients undergoing biliary ERCP who have a history of prior biliary sphincterotomy. While rectal indomethacin has demonstrated benefits in preventing post-ERCP pancreatitis in high-risk patients, its utility in this specific patient subgroup remains unclear. This trial aims to determine whether prophylactic administration of indomethacin offers a measurable benefit over no intervention in this lower-risk population. Eligible patients will be identified prior to their scheduled biliary ERCP and screened for inclusion criteria. Following informed consent, participants will be randomized to receive either rectal indomethacin or no indomethacin prior to the procedure.
Interventions
DRUGindomethacin
Indomethacin 100 mg administered as a single rectal suppository immediately prior to biliary ERCP for the prevention of post-ERCP pancreatitis. Participants are randomized to receive the study intervention before the procedure.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female ≥ 18 years of age at the time of ERCP. 2. Scheduled to undergo routine biliary ERCP with documentation of a prior biliary sphincterotomy. 3. Ability to receive rectal medication. 4. Ability and willingness to comply with all study procedures and follow-up requirements. 5. Written informed consent (and assent when applicable) was obtained from the subject or the subject's legal representative, and the subject's ability to comply with the requirements of the study was confirmed.
Exclusion criteria
1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 2. Known hypersensitivity or contraindication to indomethacin, other nonsteroidal anti-inflammatory drugs, or suppository components. 3. Active gastrointestinal bleeding, history of NSAID-induced gastrointestinal ulceration, or other conditions that contraindicate NSAID use. 4. Significant renal impairment (e.g., baseline serum creatinine above institutional upper limit of normal or estimated glomerular filtration rate \< 30 mL/min/1.73 m²). 5. Current use of other NSAIDs that cannot be safely discontinued per the investigator's judgment. 6. Known chronic pancreatitis 7. Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-ERCP Pancreatitis | Within 30 days following ERCP Procedure | The incidence of post-ERCP pancreatitis (PEP) following biliary ERCP, defined using standard consensus criteria: new or worsened abdominal pain consistent with acute pancreatitis, elevation of serum amylase or lipase to at least three times the upper limit of normal within 24 hours after ERCP, and hospitalization or prolongation of planned admission attributable to pancreatitis. The outcome will be compared between participants receiving prophylactic rectal indomethacin and those receiving placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Post-ERCP Pancreatitis | Within 30 days of ERCP | Severity of post-ERCP pancreatitis classified according to standard consensus criteria as mild, moderate, or severe among participants who develop post-ERCP pancreatitis. |
| Incidence of ERCP-Related Adverse Events | Within 30 days of ERCP Procedure | Incidence of ERCP-related complications, including bleeding, infection, and perforation, occurring after the ERCP procedure. |
| Incidence of Indomethacin-Related Adverse Events | Within 30 days of ERCP Procedure | Incidence of adverse events potentially attributable to indomethacin administration, including gastrointestinal bleeding, renal dysfunction, and allergic or hypersensitivity reactions. |
| Hospital Admission Following ERCP | Within 30 of ERCP Procedure | Proportion of participants requiring hospitalization or unplanned admission following ERCP due to post-procedure complications. |
Countries
United States
Contacts
CONTACTVu Dinh, MD, PhD
PRINCIPAL_INVESTIGATORMichael Larsen, MD
University of California, San Francisco
Outcome results
None listed