HYPPO

A common complication in pancreatic surgery is postoperative pancreatic fistula (POPF), which can lead to serious consequences. There is an international study group addressing this issue and recommending a new definition and classification of postoperative acute pancreatitis. However, there is still no systematic study of the clinical impact and frequency of this complication. This study aims to investigate the relationship between biochemical changes and postoperative morbidity in pancreatic resections. Early detection of abnormalities in laboratory values will allow faster treatment of potential complications and reduce overall morbidity. These values will be collected and validated in each patient over a 12-month period. The main objective of the study is to investigate whether postoperative serum hyperamylasemia (POH) is a predictive value for the severity of postoperative acute pancreatitis (PPAP) based on the new definition of ISGPS. The study also investigates the relationship between POPF and PPAP and the predictive value of biochemical changes for severe postoperative acute pancreatitis. In addition, a clinical score is created based on the variables assessed to predict severe postoperative pancreatitis.

{ "short_title": "HYPPO", "data_mode": "900", "data_mode_number": "000002419", "official_title": "Incidence and clinical impact of serum HYperamylasemia (POH) after Pancreatectomy on Postoperative Outcome and patient safety", "accrual_state": "running", "therapeutic_value": "nonTherapeutic", "therapieansatz_value": "not_applicable", "therapieintervention_value": "not_applicable", "therapielinie_value": "not_applicable", "ctgov_number": null, "eudract_number": null, "general_contact_email": "studienzentrum-vtg@ukdd.de", "general_contact_phone": null, "hauptpruefer_dd_name": "Prof. Dr. med. Marius Distler", "description_laie_de": "Eine h\u00e4ufige Komplikation in der Pankreaschirurgie ist die postoperative Pankreasfistel (POPF), die zu schwerwiegenden Folgen f\u00fchren kann. Es gibt eine internationale Studiengruppe, die sich mit diesem Thema besch\u00e4ftigt und eine neue Definition und Einstufung der postoperativen akuten Pankreatitis empfiehlt. Allerdings gibt es noch keine systematische Untersuchung der klinischen Auswirkungen und H\u00e4ufigkeit dieser Komplikation.\r\nDiese Studie hat das Ziel, den Zusammenhang zwischen biochemischen Ver\u00e4nderungen und der postoperativen Morbidit\u00e4t bei Pankreasresektionen zu untersuchen. Durch die fr\u00fchzeitige Erkennung von Anomalien in den Laborwerten k\u00f6nnen m\u00f6gliche Komplikationen schneller behandelt und die Gesamtmorbidit\u00e4t reduziert werden. Diese Werte werden bei jedem Patienten \u00fcber einen Zeitraum von 12 Monaten erhoben und validiert.\r\n\r\nDas Hauptziel der Studie ist es, zu untersuchen, ob die postoperative Serumhyperamylas\u00e4mie (POH) ein pr\u00e4diktiver Wert f\u00fcr den Schweregrad der postoperativen akuten Pankreatitis (PPAP) ist, basierend auf der neuen Definition der ISGPS. Die Studie untersucht auch das Verh\u00e4ltnis zwischen POPF und PPAP sowie den Vorhersagewert biochemischer Ver\u00e4nderungen f\u00fcr schwere akute postoperative Pankreatitis. Dar\u00fcber hinaus wird auf der Grundlage der bewerteten Variablen ein klinischer Score erstellt, um eine schwere postoperative Pankreatitis vorherzusagen.", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "A common complication in pancreatic surgery is postoperative pancreatic fistula (POPF), which can lead to serious consequences. There is an international study group addressing this issue and recommending a new definition and classification of postoperative acute pancreatitis. However, there is still no systematic study of the clinical impact and frequency of this complication.\r\nThis study aims to investigate the relationship between biochemical changes and postoperative morbidity in pancreatic resections. Early detection of abnormalities in laboratory values will allow faster treatment of potential complications and reduce overall morbidity. These values will be collected and validated in each patient over a 12-month period.\r\n\r\nThe main objective of the study is to investigate whether postoperative serum hyperamylasemia (POH) is a predictive value for the severity of postoperative acute pancreatitis (PPAP) based on the new definition of ISGPS. The study also investigates the relationship between POPF and PPAP and the predictive value of biochemical changes for severe postoperative acute pancreatitis. In addition, a clinical score is created based on the variables assessed to predict severe postoperative pancreatitis.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 2, "sub_cat_id": 4 }

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