Risk Factors of Post-ERCP Pancreatitis in Patients Receiving Rectal Indomethacin

Risk Factors Related to Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-risk Patients Who Underwent ERCP and Received Prophylactic Rectal Indomethacin

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02709421

Enrollment

790

Registered

2016-03-16

Start date

2016-02-29

Completion date

2016-09-30

Last updated

2016-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

post-Endoscopic Retrograde cholangiopancreatography pancreatitis, Risk factors, Indomethacin

Brief summary

Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis (PEP)remains the most frequent adverse event of ERCP. Rectal indomethacin, as one kind of classic NSAIDs, has been proved to be effective in reducing the incidence of PEP. It has been widely used to prevent PEP in patients, especially those with potentially high risks of PEP. However, rectal indomethacin can not completely eradicate the occurrence of PEP. The rate of PEP in patients receiving indomethacin ranges from 3.2% to 9.2%. The risk factors of PEP in patients receiving rectal indomethacin remains unclear. The aim of the study was to identify potential risk factors in high-risk patients whose received administration of prophylactic rectal indomethacin after ERCP.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Undergoing diagnostic or interventional ERCP * Receiving administration of rectal indomethacin(100mg) after ERCP * High risk patients determined at the discretions of endoscopists

Exclusion criteria

* Dose other than 100mg * Acute pancreatitis within 3 days before ERCP * Average risk patients at the discretions of endoscopists * Using NSAIDs within 7 days before ERCP * Without cannulation attempts * Administration of rectal indomethacin before or during ERCP

Design outcomes

Primary

Measure	Time frame	Description
Overall PEP rate	1 year	PEP was defined if patients experienced abdominal pain for more than 24h after procedure, accompanying with amylase or lipase ≥ 3 times equal to the upper limit of normal value.

Secondary

Measure	Time frame
The rate of moderate-severe pancreatitis	1 year
Overall ERCP-related complication rate	1 year

Countries

China

Outcome results