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

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

— PIPAC-GRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04779385
• Other study ID #: CHUGA
• Status: Completed
• Start date: November 16, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: February 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 30, 2021
• Est. primary completion date: February 28, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients

• Patients treated with PIPAC and monitored for peritoneal carcinoma

• Patients informed

Exclusion Criteria:

• Patients opposition

Related Conditions & MeSH terms

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

Intervention

Procedure:
• PIPAC
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.

Locations

Country	Name	City	State
France	CHUGA	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the cost of a PIPAC	Evaluate the cost of a PIPAC procedure and the associated hospital stay	90 Days