NCT03210298

International Registry of Patients Treated With Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC)

Multicenter, International Online Documentation of Indications and Results of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC Und PITAC) for Treating Malignant Peritoneal and Pleural Diseases

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Sabine Rhode · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Peritoneum Cancer
• Peritoneum Neoplasm
• Pleural Cancer
• Pleural Effusion
• Pleural Mesothelioma
• Ovarian Cancer
• Gastric Cancer
• Appendix Cancer
• Pseudomyxoma Peritonei
• Colorectal Cancer
• Pancreas Cancer
• Gallbladder Cancer
• Ascites
• CUP
• Chemotherapeutic Toxicity

Interventions

Type	Name	Description
COMBINATION_PRODUCT	PIPAC	A chemotherapeutic solution is aerosolized into the expanded abdominal cavity during laparoscopy, under pressure. This allows a relatively homogeneous repartition of the drug and an effective tissue penetration.

Timeline

• Start date: 2016-01-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2017-07-06
• Last updated: 2019-10-08

Locations

16 sites across 13 countries: Argentina, Australia, Austria, Belgium, Denmark, France, Germany, Italy, Poland, Russia, Singapore, Spain, Switzerland

Regulatory

• FDA-regulated drug study