Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care

Solid Cancer in a Palliative Situation With Ascites Clinical Trial

— AGASA-SP  

Official title:

Serum-Ascites Albumin Gradient Analysis in Cancer Patients in Palliative Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03463655
• Other study ID #: AGASA-SP-IPC 2017-004
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2018
• Last updated: March 12, 2018
• Start date: December 21, 2017
• Est. completion date: April 2018

Study information

• Verified date: March 2018
• Source: Institut Paoli-Calmettes
• Contact: Aurélien PROUX
• Phone: 0491227643
• Email: PROUXA[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Current recommendations do not recommend the concomitant administration of albumin after ascites puncture in patients with ascites neoplasia unlike cirrhotic ascites. The etiology of ascites in cancer patients is multifactorial, particularly by hepatic invasion that can lead to ascites loaded with albumin. Ascites punctures therefore lead to undernutrition, recurrent early ascites by decreasing the oncotic pressure by hypo albuminemia and a state of anasarca affecting the quality of life.

Description:

According to the recommendations, each ascites fluid must be sent for biochemical and bacteriological analysis.

Demonstrate the high gradient proportion (percent only, no threshold of significance required). The literature has already validated the importance of supplementing albumen with cirrhotic ascites. Demonstrating that some cancer patients have high gradients, this will be enough to make the practitioner think to supplement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years of age followed for a solid cancer in a palliative metastatic situation who had a puncture of ascites.

Exclusion Criteria:

• Minor patient

• Known cirrhosis

Related Conditions & MeSH terms

• Ascites
• Solid Cancer in a Palliative Situation With Ascites

Intervention

Diagnostic Test:
• cirrhotic albumin
Ascites puncture
• serum albumin
blood punctures

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (3)

Ayantunde AA, Parsons SL. Pattern and prognostic factors in patients with malignant ascites: a retrospective study. Ann Oncol. 2007 May;18(5):945-9. Epub 2007 Feb 13. — View Citation

Carrier P, Jacques J, Debette-Gratien M, Legros R, Sarabi M, Vidal E, Sautereau D, Bezanahary H, Ly KH, Loustaud-Ratti V. [Non-cirrhotic ascites: pathophysiology, diagnosis and etiology]. Rev Med Interne. 2014 Jun;35(6):365-71. doi: 10.1016/j.revmed.2013.12.001. Epub 2014 Jan 6. Review. French. — View Citation

Guide pratique des soins palliatifs Edition A.P.E.S. (2008)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum-Ascites Albumin Gradient Prevalence	Elevated Serum-Ascites Albumin Gradient Prevalence in Palliative Cancer Patients	3 months
Secondary	Metastatic sites	Number of Metastatic sites of patients with a high gradient.	3 months