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

NCT04779385 | Completed

• 1 other identifier: CHUGA
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the cost of a PIPAC

  Evaluate the cost of a PIPAC procedure and the associated hospital stay

  90 Days

Interventions

PIPAC PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peritoneal carcinomatosis of any origin treated with PIPAC.

You may qualify if:

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

You may not qualify if:

• Patients opposition

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHUGA

Grenoble, France

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 3, 2021
• Study Start: November 16, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 30, 2021
• Last Updated: May 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)