GERPACYST- A GERMAN PANCREAS CLUB CYST REGISTRY: A PROTOCOL FOR A PROSPECTIVE, MULTICENTER, INTERDISCIPLINARY REGISTRY STUDY
Jonathan Marschner2, Ulrich F. Wellner*2, Julia Bertram2, Steffen Deichmann2, Marko Damm1, Sebastian Krug1, Christoph Michalski3, Tobias Keck2, Kim C. Honselmann2
1Universitatsklinikum Halle, Halle, Sachsen-Anhalt, Germany; 2Universitatsklinikum Schleswig Holstein Campus Lubeck, Lubeck, Schleswig-Holstein, Germany; 3Universitatsklinikum Ulm, Ulm, Baden-Württemberg, Germany
Introduction. Cystic lesions of the pancreas continue to present a clinical challenge. They include pancreatic cystic neoplasms such as IPMN (intraductal papillary-mucinous neoplasia), MCN (mucinous-cystic neoplasia), SCA (serous cystic adenoma), and SPN (solid pseudopapillary neoplasia). Pancreatic cysts are detected much more frequently due to improvements in imaging. Especially small cysts (<3cm) have an uncertain malignancy potential. International guidelines for the treatment of pancreatic cysts show considerable differences due to the lack of high-quality data on the biology of pancreatic cysts.
Consequently, it is difficult to find a balance between the risk of malignant progression and overtreatment by follow-up investigations or surgical intervention.
GerPaCyst aims to establish a multi-center interdisciplinary pancreatic cyst registry across Germany, which will contribute to the discovery of the natural entity specific biology, resulting in the calculation of a risk model for the assessment of the individual malignancy potential of each pancreatic cyst.
Materials and methods
Participating centers complete an electronic Case Report Form via REDCap (web-based software) and add changes in patient characteristics during patient follow-up (typically every 6-12 months). Patients must be diagnosed with a pancreatic cyst and at minimum 18 years old. The regular treatment of patients in the specific center is not affected by the implementation of the study.
Duration of observation per patient is up to a maximum of 20 years or until the occurrence of an event defined as suspected malignancy (and resection, if applicable) or death. Each center will be able to submit their own additional research questions for analysis.
Results
So far 10 university (-affiliated) hospitals with their departments for surgery and gastroenterology throughout Germany are participating in this study. A positive ethics vote of the initiating center is provided. All participating centers will sign the study contract before initiation. At least 5000 patients will be recruited in the participating centers. Baseline characteristics such as metabolic diseases, risk factors, as well as pancreatic cyst data including main pancreatic duct diameter, enhanced mural nodules and the quality-of-life EQ-5 questionnaire will be assessed during index visit and follow-up.
Conclusion
GerPaCyst will provide a valuable platform for clinical outcomes research. Fundamental factors affecting the development of pancreatic cysts will be identified. We hope to collect high quality data predicting the risk of malignancy.
Back to 2023 Posters