Honselmann, Kim Christin and Marschner, Jonathan and Staufenbiel, Anna and Bertram, Julia and Deichmann, Steffen and Engelke, Carsten and Kirstein, Martha and Marquardt, Jens and Damm, Marko and Borowitzka, Fanny and Phillip, Veit and Pergolini, Ilaria and Harder, Felix and Braren, Rickmer and Gemoll, Timo and Kleger, Alexander and Felsenstein, Matthaeus and Schlosser-Hupf, Sophie and Birth, Matthias and Bolm, Louisa and Braun, Ruediger and Demir, Ihsan Ekin and Denzinger, Maximilian and Drews, Beate and Dugic, Ana and Ewers, Thomas and Grandi, Josephine-Alisa and Haberer, Susanne and Ammer-Hermenau, Christoph and Hildebrandt, Philipp and Huettner, Felix and Janke, Katja and Kilani, Katja and Lamprecht, Georg and Michaelis, Jolina and Neesse, Albrecht and Perkhofer, Lukas and Rasch, Sebastian and Reichert, Maximilian and Sauer, Thorben and Müller-Schilling, Martina and Schuette, Jens and Wilke, Rene and Roth, Susanne and Krug, Sebastian and Michalski, Christoph W. and Jaster, Robert and Keck, Tobias and Wellner, Ulrich Friedrich (2025) GerPaCyst - The trial protocol of the prospective, multicenter, interdisciplinary German Pancreas Club Cyst Registry. PLOS ONE, 20 (11): e0335809. ISSN , 1932-6203
Full text not available from this repository. (Request a copy)Abstract
Introduction Cystic lesions of the pancreas have continued to present a clinical challenge for the past decades now. The increasing rate of detection, the lack of high-quality data on the natural biology of pancreatic cysts and the resulting difficulty to predict malignant transformation in different types of pancreatic cysts make patients with these diseases hard to manage. The German Pancreas Club Cyst Registry (GerPaCyst) (DRKS00025927) aims to establish a platform to discover and survey the natural and specific biology of pancreatic cysts such as IPMNs (main and branch ducts), SCNs, SPPT and MCNs, in a multicenter manner.Materials and methods This manuscript is written according to the SPIRIT guidelines (See S2 and S3 Tables). Ethical approval was obtained from the University of Luebeck (2020-20-225) and all participating centers. In GerPaCyst patients aged >= 18 years with a pancreatic cyst under surveillance or scheduled for surgery should be enrolled. Participating centers will complete an electronic Case Report Form (eCRF) via REDCap which is designed as a longitudinal study minimizing the input of repeated measures. Changes in patient baseline data, cyst characteristics, both endoscopic and imaging data will be entered typically every 6-12 months during patient follow-up. Biobanking will be performed, when available. Duration of observation per patient is up to a maximum of 20 years or until end of follow-up or death.Results The primary goal is to assess and calculate individual risk models for malignancy/high-grade dysplasia based on the collected clinical, molecular and imaging data (multi-omics prediction models) for each included cyst entity, therefore the primary outcome of this trial is the development of high-grade dysplasia/invasive cancer during follow-up or the absence of it. The secondary outcomes are death, quality of life measured by EQ-5D-5L questionnaire, end-of-follow up and perioperative characteristics, if applicable such as complications, length of hospital stay and clavien-dindo classification. Another goal will be to build a multicenter, interdisciplinary database to generate high-quality cyst biology data, which can then be used for further research questions. Additionally, this database will be utilized for registry- based interventional trials in the future.Discussion GerPaCyst will provide a valuable platform for clinical outcomes research. Fundamental factors affecting the development of pancreatic cysts over time will be identified. New research questions might be answered during the study period and will be made available through continuous publications.Trial registration The study was prospectively registered at the German Clinical Trial Register (DRKS) under DRKS00025927 on September 14th, 2021, before inclusion of the first patient. The Universal Trial Number (UTN) is U1111-1302-9822.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | PAPILLARY MUCINOUS NEOPLASMS; MANAGEMENT; MALIGNANCY; RISK; PROGRESSION; GUIDELINES; DIAGNOSIS; MORTALITY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 31 Mar 2026 10:17 |
| Last Modified: | 31 Mar 2026 10:17 |
| URI: | https://pred.uni-regensburg.de/id/eprint/67817 |
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