CClinicalTrials.gg
Status unknownNCT04770857PEP-PREPAREUpdated Jul 29, 2021

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

An observational study in Post-ERCP Acute Pancreatitis, sponsored by Nicola Frei. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Nicola Frei · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Post-ERCP Acute Pancreatitis

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In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 180 across 277 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

This is the only study on the registry with Nicola Frei as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients scheduled for ERCP for any reason at the study center will be asked for participation.

Inclusion criteria

  • Age >18 years
  • Scheduled for ERCP for any reason

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Interventions

  • OtherVisual analogue scale

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

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What researchers measure

Primary outcomes

  1. Association between Pain 1 hour after ERCP

    Time frame: 1 hour

Secondary outcomes

  1. Predictive value of VAS for PEP Predictive value of VAS for PEP

    Time frame: 1 hour

  2. Association between VAS level and severity of PEP

    Time frame: 1 hour

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Study locations

1 site
  • Kantonsspital Sankt Gallen
    Sankt Gallen, 9007, Switzerland
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04770857
Lead sponsor
Nicola Frei
Responsible party
Nicola Frei (MD, Cantonal Hospital of St. Gallen) — Sponsor-investigator
First posted
Feb 25, 2021
Start date
Sep 1, 2021 (estimated)
Primary completion
May 2023 (estimated)
Completion
Aug 2023 (estimated)
Last update
Jul 29, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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