Clinical Trial on Post-ERCP Acute Pancreatitis - Clinical Trials Registry

Study Overview

Status

Enrolling by invitation

Conditions

Post-ERCP Acute Pancreatitis

Detailed Description

In 2017, a new guideline addressing the quality in ERCP entitled "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative" was published. The focus of the quality improvement committee (QIC) of the ESGE is to ensure high standard of all endoscopy examinations throughout Europe by adhering to quality-improving factors (key performance indicators and minor performance indicators as defined by the ESGE).

The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Endoscopy (ESGE) will actually lead to an improvement in quality.

The study will compare the quality development in endoscopy based on following time intervals:

before introduction of the QIC-initiative (before 2017)
after the introduction of the initiative (2017-2023) (both retrospective data),
prospectively, from 2024 onwards.

The primary endpoint of this study will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%.

The investigators hope that this study will lead to even greater patient safety in the future by improving findings and examination quality and therefore reduce the incidence of post-ERCP pancreatitis. In addition, the aim is to harmonize the high endoscopic standards throughout Europe.

Study Type

Observational

Enrollment (Estimated)

1254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Warendorf, Germany, 48231
    - University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria

Age under 18 years
Inability to understand information for participation
Refusal of participation, missing cooperativity, e.g., due to age or disease
Pregnant or lactating patients
Patients with > 1 ERCP during the hospital stay: only the initial ERCP will be evaluated

Description

Inclusion Criteria:nclusion criteria Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria

Exclusion criteria

Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria
Age under 18 years
Inability to understand information for participation
Refusal of participation, missing cooperativity, e.g., due to age or disease
Pregnant or lactating patients
Patients with > 1 ERCP during the hospital stay: only the initial ERCP will be evaluated

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group before introduction of the QIC-initiative (before 2017) The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%.
Group after introduction of the QIC-initiative (2017-2023) The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%.
Prospective Group The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-ERCP pancreatitis (PEP) Time Frame: 2016 - 2025	Comparison of the incidence of PEP before and after the implementation of the guideline. i. Clinical illness with typical pain (physical examination: pain in the upper belly with/without radiation to the back, tenderness when touching the belly) ii. laboratory testing with 3x increase of lipase (or amylase) iii. Characteristic findings in CE-CT, MRI or transabdominal sonography iv. Requiring extension of hospital stay	2016 - 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate antibiotic prophylaxis before ERCP Time Frame: 2016 - 2025	Rate of adequate antibiotic prophylaxis before ERCP	2016 - 2025
Bile duct cannulation Time Frame: 2016 - 2025	Rate of successful bile duct cannulation	2016 - 2025
Appropriate stent placement in patients with biliary obstruction below the hilum Time Frame: 2016 - 2025	Rate of appropriate stent placement in patients with biliary obstruction below the hilum	2016 - 2025
Bile duct stone extraction Time Frame: 2016 - 2025	Rate of successful bile duct stone extraction	2016 - 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Münster

Collaborators

University of Copenhagen

University Hospital Muenster

University of Kiel

Johannes Gutenberg University Mainz

Investigators

Principal Investigator: Dirk Domagk, MD, Universität Münster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

November 28, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)