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Cost and Effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy in Patients With Peritoneal Carcinoma.

Cost and Effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Peritoneal Carcinoma.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04779385
Acronym
PIPAC-GRE
Enrollment
50
Registered
2021-03-03
Start date
2020-11-16
Completion date
2021-03-30
Last updated
2021-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluate the Cost of a PIPAC Procedure and the Associated Hospital Stay in France

Brief summary

The presence of peritoneal carcinomatosis indicates a neoplastic disease evolved. Without intervention, the prognosis is poor with survival of only a few months. Standard treatment is based on systemic chemotherapy, however, the pharmacokinetics of drug delivery to the peritoneum is poor, with limited efficacy compared to other metastatic sites such as the liver or lung. When the carcinomas are is resectable, selected patients can benefit from targeted therapeutic approaches combining peritonectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC), offering a significant improvement in survival. A new surgical technique has been developed for patients with unresectable Chemotherapy intraperitoneal aerosol spray (PIPAC). The objective is to improve the survival time, quality of life but can also make PC resectable and therefore accessible to complete excisional surgery. The cost of this treatment is not yet fully assessed in France. The main objective of this study is to assess the real cost of PIPAC in order to allow its dissemination.

Interventions

PROCEDUREPIPAC

under general anaesthesia, a laparoscopy was performed using an open laparoscopic technique to prevent intestinal wounds, which would contraindicate the procedure. A 12 mmHg pneumoperitoneum was created, and to ensure the safety of the procedure the pressure of the pneumoperitoneum was maintained constant throughout the procedure. Two laparoscopic balloon trocars (of 11 and 12 mm) were used. A thorough exploration of the abdomen, Peritoneal Cancer Index assessment, images, peritoneal biopsies, and ascites cytology (in the case of ascites) were performed prior to administration of the chemotherapy aerosol. For carcinomas of gastric origin, Doxurubicin at a dose of 1.5 mg/m2 was administered in combination with Cisplatin 7.5 mg/m2 diluted in 40 and 150 mL of 0.9% sodium chloride, respectively. In the case of contraindication, Oxaliplatine at a dose of 92 mg/m2 in a 5% dextrose solution was recommended.

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Adult patients * Patients treated with PIPAC and monitored for peritoneal carcinoma * Patients informed

Exclusion criteria

* Patients opposition

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the cost of a PIPAC90 DaysEvaluate the cost of a PIPAC procedure and the associated hospital stay

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026