CHUGA
Grenoble, France
Completed
NCT Number: NCT04779385
Cost and Effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy in Patients With Peritoneal Carcinoma.
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.
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Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult patients
- Patients treated with PIPAC and monitored for peritoneal carcinoma
- Patients informed
Exclusion criteria
- Patients opposition
Treatment and study plan
PIPAC
Procedureunder 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.
Primary outcomes
-
Evaluate the cost of a PIPAC
Time frame: 90 Days
Evaluate the cost of a PIPAC procedure and the associated hospital stay
Sponsors and collaborators
Lead sponsor
University Hospital, Grenoble
Other
Registry information
Official study title
Cost and Effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Peritoneal Carcinoma.
Acronym: PIPAC-GRE
Important dates
- Study start
- 2020
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Mar 3, 2021
- Registry last updated
- May 5, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.