Aims:
Monitoring the efficacy and safety of invasive endoscopic procedures is crucial. One
of the primary aims of our registry is to monitor relevant outcome data of ERCP.
Methods:
Hungarian experts in ERCP were invited at the initiation of the registry for discussion
and consensus. A web-based case report form (https://ercp.tm-pte.org/) was developed
and tested from January 2017 at our department.
Results:
ERCP related data of consecutive patients were collected prospectively after approval
by the Scientific and Research Ethics Committee and after informed consent from the
patients. The data from the first 400 procedures of 301 patients were analyzed to
demonstrate the usability of the registry. Difficult biliary access was observed in
56 of 207 (27.1%) cases with native papilla, and 48 (85.7%) of them had successful
biliary access at the first ERCP. Successful biliary cannulation was achieved in 93.8%
of all procedures where the papilla was reached. Immediate complications were observed
in 43 cases (10.75%), 19 mild (4.75%) and 2 (0.5%) moderate severe bleeding, 18 cases
of hypoxia occurred (4.5%, all mild). Only 4 mild and 2 moderately severe post-ERCP
pancreatitis developed (1.5%). Cholangitis was observed in 4 cases (1%), while late
bleeding in 2 cases (0.5%, moderate severity). Follow-up was conducted 30 days after
the ERCP by a telephone call and/or reviewing health care documentations to observe
long-term outcome in 231 patients (76.3%). 16 patients (6.9%) died during this period,
but only 1 (0.4%) death was related to the procedure (due to unresolved cholangitis).
All other quality indicators can be monitored by using the ERCP registry.
Conclusions:
The ERCP registry is an essential tool for measuring quality indicators. The universal
usage will allow benchmarking at individual, institutional and national level and
will help in quality improvement. Effectivity, safety and impact on different pancreatobiliary
disorders will be also measurable.
