Abstract
ObjectivesSeveral trials have documented the favorable safety profile, and promising clinical results of pressurized intraperitoneal aerosol chemotherapy (PIPAC) directed treatment in different types of peritoneal malignancies. However, until the results of randomized trials are available, the quality of documentation and acceptance by the users may be improved through a worldwide registry. The International Society for the Study of Pleura and Peritoneum (www.ISSPP.org) facilitated this process by creating a dedicated focus group and providing the funding needed for the creation and implementation of an international database. This article describes the design and the journey of establishing this international database and the first, preliminary results from the ISSPP PIPAC online database.MethodsIn 2019 the ISSPP PIPAC Registry Group started to create a database with a minimal dataset relevant to many diseases and applicable in different framework conditions. The task was divided into three phases including design, testing, implementation, protocol, handbook, legal requirements, as well as registry rules and bylaws for the registry group.ResultsThe ISSPP PIPAC online database has six key elements (patient, consent, treatment, complications, response evaluation and follow-up). Following design, testing and implementation the database was successfully launched in June 2020. Ten institutions reported on 459 PIPAC procedures in 181 patients during the first 6 months, and the recorded data were comparable to the present literature.ConclusionsA new international multicenter PIPAC database has been developed, tested and implemented under the auspices of ISSPP. The database is accessible through the ISSPP website (www.ISSPP.org), and PIPAC institutions worldwide are highly encouraged to participate.
Highlights
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is an innovative drug delivery technique designed to improve the effect of intraperitoneal administered chemotherapeutic agents [1]
The database is accessible through the ISSPP website, and pressurized intraperitoneal aerosol chemotherapy (PIPAC) institutions worldwide are highly encouraged to participate
The ISSPP PIPAC database and the study protocol were approved by the Region of Southern Denmark (GDPR, 20/18204) on April 21st, 2020; the Institutional Review Board of the University of Southern Denmark (SDU REC 20/24559) on May 5th, 2020 and by the hosting unit Odense Patient data Explorative Network (OPEN) on May 19th, 2020 (OP-1140, 19/49984)
Summary
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is an innovative drug delivery technique designed to improve the effect of intraperitoneal administered chemotherapeutic agents [1]. Several phase I and II trials have documented the favorable safety profile, and promising clinical results of PIPAC directed treatment in different types of peritoneal malignancies [2,3,4,5,6,7,8]. Until the results of randomized trials are available, PIPAC cannot be considered as a standard-of-care method [9,10,11]. PIPAC is a generic technique, and potential indications are numerous, including rare diseases. Well-known chemotherapeutic drugs are applied (cisplatin, oxaliplatin, doxorubicin, nabpaclitaxel, etc.), but none of these drugs is approved for intraperitoneal delivery. Further challenges are occupational health safety, regulatory issues, reimbursement (in the absence of cost-effectiveness data), and the involvement of a wide range of dedicated specialists and institutions
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