"GERPACYST- The Trial Protocol Of The Prospective, Multicenter, Interdisciplinary German Pancreas Club Cyst Registry"

BackgroundCystic 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) establishes a platform to discover the natural entity specific biology of pancreatic cysts, in a multicenter manner that should allow to assess risk models for malignancy. MethodThis manuscript is written according to the SPIRIT guidelines. Ethical approval was obtained from the University of Luebeck (2024-265_1). 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. DiscussionGERPACYST 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. Trial registrationThe 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. Trial sponsorThe study is sponsored by the German Pancreas Club (DPC) e.V. The sponsor has no role in study design, collection, management, interpretation or writing of the report. It is a mere supportive sponsoring.