NCT04032600

Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ATLANTIS-study was designed to determine the safety of a full paracentesis in patients with malignant ascites due to ovarian cancer. The underlying hypothesis states, that full paracentesis does not impair safety, compared to fractioned paracentesis with clamping of the drain. Half of the patients will receive a full paracentesis, while the other half will receive fractioned paracentesis with clamping of the drain after 3 liters of ascites was evacuated. All patients receive extensive monitoring of hemodynamics and kidney function.

Detailed description

Background: Malignant ascites is common in ovarian cancer and often causes symptoms such as abdominal pressure and shortness of breath, resulting in an decreased quality of life for the patient. Paracentesis is a safe and easy method for symptom relief. But no guidelines exist on the management of ascites drainage in ovarian cancer. In many cases a partial paracentesis is performed, due to fear of hemodynamic instability or kidney failure, with partial drainage of the intraperitoneal fluid on the first day and subsequent drainage on the next day. As there is no study that reported a deteriorated health due to full paracentesis in ovarian cancer, the decision whether a partial or total paracentesis is performed depends entirely on the department or the physician. Since a total paracentesis can be performed as an out-patient treatment, this approach is often preferred by the patient. Full paracentesis is also more efficient and cost-effective. The objective of the ATLANTIS-study is to prove the safety of total paracentesis regarding hemodynamic changes and kidney failure. Methods: ATLANTIS is a randomized, prospective, clinical study that aims to include 60 patients. Patients with histologically confirmed epithelial ovarian, fallopian tube and peritoneal cancer are randomized into two arms: Partial (3 Liter) and total paracentesis. Before, during and for two hours after the paracentesis, an advanced hemodynamic monitoring is performed to ensure the patients' safety. The monitoring includes mean arterial pressure and stroke volume. After the initial phase of extensive monitoring (2 hours), the blood pressure is measured for a period of 24 hours to evaluate not only short term, but also long-term hemodynamic changes. Before and 24 hours after the paracentesis, blood samples are analyzed to detect a potential acute kidney failure.

Conditions

• Malignant Ascites
• Ovarian Cancer
• Hemodynamic Instability

Interventions

Type	Name	Description
PROCEDURE	Paracentesis	Full versus partial paracentesis (3 liters)

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-08-09
• Completion: 2019-09-09
• First posted: 2019-07-25
• Last updated: 2020-12-08

Locations

1 site across 1 country: Germany