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Evaluation of Post-ERCP Pain as a Predictor for Post-ERCP Pancreatitis

Evaluation of Post-Post-Endoscopic Retrograde Cholangiopancreaticography Pain (ERCP) as a Predictor for Post-ERCP Pancreatitis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04770857
Acronym
PEP-PREPARE
Enrollment
1000
Registered
2021-02-25
Start date
2021-09-01
Completion date
2023-08-31
Last updated
2021-07-29

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

Conditions

Post-ERCP Acute Pancreatitis

Brief summary

Pancreatitis is the most common complication after ERCP, although its frequency varies significantly depending on the study from \< 2% up to 40%. Based upon data from studies that have included unselected patients, post-ercp pancreatitis (PEP) is mild, moderate, and severe in 45%, 44%, and 11% of cases, respectively. Dysfunction of the sphincter Oddi, female gender, younger age, previous history of pancreatitis, prolonged procedure time and pancreatic guidewire passages are well-known independent risk factors for PEP. This study will assess whether the development of PEP can be predicted by Visual analogue scale (VAS) level 1 hour after ERCP.

Interventions

Post procedural pain assessment using the visual analogue scale (VAS) will be performed in patients undergoing ERCP

Sponsors

Nicola Frei
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>18 years * Scheduled for ERCP for any reason

Exclusion criteria

* Absence of consent * Language barrier * No endoscopic advance to the papilla vateri * Active pancreatitis at the time of the procedure * Mental disability

Design outcomes

Primary

MeasureTime frame
Association between Pain 1 hour after ERCP1 hour

Secondary

MeasureTime frame
Predictive value of VAS for PEP Predictive value of VAS for PEP1 hour
Association between VAS level and severity of PEP1 hour

Countries

Switzerland

Contacts

Primary ContactNicola Fabian Frei, MD
nicolafabian.frei@kssg.ch+41 71 494 99 68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026