Colorectal Cancer Clinical Trial
Official title:
Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases
Multicentric, international, web-based prospective documentation of the indications and results of Pressurized Aerosol Chemotherapy (so-called PIPAC or PITAC) for treating malignant pleural and peritoneal diseases. Indication is decided by the treating physician. There are no predefined inclusion or exclusion criteria.
All data entered into the registry documenting the patient cohort characteristics (disease,
demography, therapy) are analyzed using descriptive statistics. Survival data are analyzed
with Kaplan-Meier statistics. Multivariate Cox Proportional Hazard Models are used to
identify potential prognostic and predictive factors. In particular, a risk- adjusted
comparison of the outcome criteria with a propensity score is planned.
The data are stored in a SQL-based online database. Patient data are pseudoanonymized. The
registry has received approval of the data protection officer of the State of
Northrhine-Westphalia.
The study steering committee is blinded towards the identity of the participating
institutions. Each participating institution receives an annual report with own data vs.
benchmark. Scientific analysis can be proposed by the steering committee, by a participating
institution or by other scientists, subjected to the approval of the independent scientific
advisory board.
An export function has been built in to allow data exchange with the HIPEC Registry of the
German Society for General and GI surgery (http://www.dgav.de/studoq/studoqhipec.html).
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