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

• Conditions: Solid Cancer in a Palliative Situation With Ascites
• Interventions: Diagnostic Test: cirrhotic albumin; Diagnostic Test: serum albumin

• Registration Number: NCT03463655
• Lead Sponsor: Institut Paoli-Calmettes

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-12-21
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-12
• Last Update Submitted: 2018-03-12
• Study First Posted: 2018-03-13
• Last Update Posted: 2018-03-13
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
solid cancer in a palliative situation with ascites	cirrhotic albumin	Patient over the age of 18, followed for a solid cancer in a palliative metastatic situation, having had a puncture of ascites.
solid cancer in a palliative situation with ascites	serum albumin	Patient over the age of 18, followed for a solid cancer in a palliative metastatic situation, having had a puncture of ascites.

Primary Outcome Measures

Name	Time	Method
Serum-Ascites Albumin Gradient Prevalence	3 months	Elevated Serum-Ascites Albumin Gradient Prevalence in Palliative Cancer Patients

Secondary Outcome Measures

Name	Time	Method
Metastatic sites	3 months	Number of Metastatic sites of patients with a high gradient.

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Bouches Du Rhone, France