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

NCT ID: NCT04770857

Last Updated: 2021-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Visual analogue scale

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nicola Frei

OTHER

Sponsor Role lead

Responsible Party

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Nicola Frei

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kantonsspital Sankt Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Nicola Fabian Frei, MD

Role: CONTACT

+41 71 494 99 68

Facility Contacts

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Nicola Fabian Frei, MD

Role: primary

+41 71 494 99 68

Other Identifiers

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CTU 19/036

Identifier Type: -

Identifier Source: org_study_id

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