NCT04770857

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

1.7 years

First QC Date

February 22, 2021

Last Update Submit

July 28, 2021

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Association between Pain 1 hour after ERCP

    1 hour

Secondary Outcomes (2)

  • Predictive value of VAS for PEP Predictive value of VAS for PEP

    1 hour

  • Association between VAS level and severity of PEP

    1 hour

Interventions

Visual analogue scaleOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Sankt Gallen

Sankt Gallen, 9007, Switzerland

Location

Central Study Contacts

Nicola Fabian Frei, MD

CONTACT

+41 71 494 99 68nicolafabian.frei@kssg.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 22, 2021

First Posted

February 25, 2021

Study Start

September 1, 2021

Primary Completion

May 1, 2023

Study Completion

August 1, 2023

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

CH(1)