Skip to content

ESGE-Quality Improvement in Endoscopy: ERCP

Quality Improvement in Endoscopy: Has the Implementation of the ESGE Guideline 2017 Led to a Reduction in Post-ERCP Pancreatitis? A Multicenter Trial

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06727851
Acronym
QIC_ERCP
Enrollment
1254
Registered
2024-12-11
Start date
2024-01-01
Completion date
2026-07-01
Last updated
2024-12-11

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

Conditions

Post-ERCP Acute Pancreatitis

Keywords

performance measures, ESGE, post-ERCP pancreatitis, quality in endoscopy

Brief summary

The primary aim of the present study is to compare the incidence of post-ERCP pancreatitis (PEP) before and after the implementation of the QIC-guideline in 2017: Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative.

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: 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 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.

Interventions

None listed

Sponsors

University of Kiel
CollaboratorOTHER
University of Copenhagen
CollaboratorOTHER
Johannes Gutenberg University Mainz
CollaboratorOTHER
University Hospital Muenster
CollaboratorOTHER
Universität Münster
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

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

Design outcomes

Primary

MeasureTime frameDescription
Post-ERCP pancreatitis (PEP)2016 - 2025Comparison 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

Secondary

MeasureTime frameDescription
Bile duct stone extraction2016 - 2025Rate of successful bile duct stone extraction
Adequate antibiotic prophylaxis before ERCP2016 - 2025Rate of adequate antibiotic prophylaxis before ERCP
Bile duct cannulation2016 - 2025Rate of successful bile duct cannulation
Appropriate stent placement in patients with biliary obstruction below the hilum2016 - 2025Rate of appropriate stent placement in patients with biliary obstruction below the hilum

Countries

Germany

Outcome results

None listed

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