The ISSPP PIPAC database: design, process, access, and first interim analysis

Michael Bau Mortensen; Olivier Glehen; Philipp Horvath; Martin Hübner; Kim Hyung-Ho; Alfred Königsrainer; Marc Pocard; Marc Andre Reymond; Jimmy So; Claus Wilki Fristrup

doi:10.1515/pp-2021-0108

The ISSPP PIPAC database: design, process, access, and first interim analysis

Pleura Peritoneum. 2021 Apr 22;6(3):91-97. doi: 10.1515/pp-2021-0108. eCollection 2021 Sep.

Authors

Affiliations

¹ Department of Surgery, Odense PIPAC Center and Odense Patient data Explorative Network (OPEN), Odense University Hospital, Sdr. Boulevard, DK-5000Odense C, Denmark.
² Department of Surgical Oncology, Centre Hospitalier Lyon Sud, Pierre Bénite, France.
³ Department of General, Visceral and Transplant Surgery, University of Tübingen, Tübingen, Germany.
⁴ Department of Visceral Surgery, Lausanne University Hospital (CHUV), University of Lausanne (UNIL), Lausanne, Switzerland.
⁵ Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea.
⁶ Department of Surgery, Pitie Salpêtriére University Hospital, Paris, France.
⁷ Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
⁸ Department of Surgery, Odense University Hospital, Odense, Denmark.

Abstract

Objectives: Several 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.

Methods: In 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.

Results: The 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.

Conclusions: A 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.

Keywords: ISSPP; PIPAC; database.