An observational study in Refractory Malignant Ascites, sponsored by Fondation Hôpital Saint-Joseph. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2018-08-14.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
The refractory malignant ascites is a complication of advanced stages of many cancer types. It is characterized clinically by abdominal pressure sensation, shortness of breath and pelvic pain. Thus, it contributes to decreased quality of life for these patients in palliative care.
Conventional treatment is based on paracentesis of ascites. The progression of the disease leads to increased production of ascites requiring more frequent paracentesis. Main therapeutic alternatives are constituted by the controversial use of diuretics and the use of an antibody inhibiting the activity of the Vascular Endothelial Growth Factor (VEGF): bevacizumab. Catumaxomab, a monoclonal antibody anti-EpCAM and CD3, developed for the treatment of refractory malignant ascites showed no sufficient clinical benefit.
VEGF is overexpressed in many tumors. VEGF causes an increase in capillary permeability and capillary filtration surface generating increased protein extravasation. These phenomena are responsible for an increase of the volume of ascites product. Thus the use of inhibitors of VEGF, such as bevacizumab, could reduce the production of ascites.
The efficacy of bevacizumab to decrease the volume of ascites product was demonstrated on small animals in intraperitoneal administration.
Studies in humans are few and the doses used are not consistent from one study to another.
Main objective / secondary:
The objective of this study is to describe the population, adverse effects, the volume of ascites product and time between paracentesis in patients receiving bevacizumab in intraperitoneal through a refractory malignant ascites.
Methodology :
This is a retrospective study mono centric and non-interventional. data collected
supports
Circulation mode and data processing and not opposition patient The anonymous data are entered on a computer file and centralized within the pharmacy department by the investigator of the Groupe Hospitalier Saint Joseph Paris, Carole METZ, to be processed locally.
For the statistical analysis, quantitative variables are expressed by their mean, standard deviations, their minimum and maximum values as appropriate. The variables will be expressed in numbers and percentages. Descriptive data analyzes, correlations between the study variables and more specific tests to determine the prognostic value of variable can be used.
This is a single-center retrospective cohort within the GHPSJ. Patients are aware of the potential use of their data in their files for medical research by information contained in the handbook of the institution for patients.
Development of the study:
252 studies on the registry are indexed under Ascites; 52 are open to participants now.
This study's enrollment of 30 is below the median of 90 across 57 observational studies indexed under Ascites.
Browse Ascites studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted with Refractory Malignant Ascites and wgho received bevacizumab intraperitoneal (IP) injection
Exclusion Criteria:
Assessment of the ascites volume
Assessment of the ascites volume (mL) collected during paracentesis prior to the introduction of IP bevacizumab
Time frame: 1 Hour before introduction of bevacizumab
Assessment of the TNM classification of the cancer
type of cancer, TNM
Time frame: Day1
Assessment of the number of paracentis happened
frequency after paracentesis after the introduction of IP bevacizumab
Time frame: Month 12
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Fondation Hôpital Saint-Joseph