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

Not Applicable

Completed

• Conditions: Ovarian Cancer; Hemodynamic Instability; Malignant Ascites
• Interventions: Procedure: Paracentesis

• Registration Number: NCT04032600
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-02-11
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-25
• Primary Completion: 2019-08-09
• Study Completion: 2019-09-09
• Last Update Submitted: 2020-12-06
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 61

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full paracentesis	Paracentesis	All ascites is drained
Fractioned paracentesis	Paracentesis	3 Liters are drained, then the drain is clamped and the rest of the ascites is drained on the next day

Primary Outcome Measures

Name	Time	Method
Change of stroke volume	20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes	Stroke volume is measured by advanced hemodynamic monitoring
Change of mean arterial pressure	20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes	Mean arterial pressure is measured by advanced hemodynamic monitoring

Secondary Outcome Measures

Name	Time	Method
Quality of life- pre and post paracentesis: EQ-5D questionnaire	2 hours before paracentesis, 24 hours after paracentesis and 1 week after paracentesis	Measured with the EuroQuol-Group 5 Dimensions - Visual analog scale (EQ-5D VAS) questionnaire, the questionnaire directs to characterize the quality of life by mobility, activities, pain and fear and subjective scale between 1 (worst) and 100 (best)
Change of stroke volume in the post-paracentesis interval	2 hours after the finish of the paracentesis	Stroke volume is measured by advanced hemodynamic monitoring
Incidence of side effects in the post-paracentesis interval	24 hours after the finish of the paracentesis	Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)
Change of mean arterial pressure in the post-paracentesis interval	2 hours after the finish of the paracentesis	Mean arterial pressure is measured by advanced hemodynamic monitoring
Ascites related symptoms- pre and post paracentesis	2 hs before paracentesis, 24-hours after paracentesis and 1 week after paracentesis	Measured with the and Functional Assessment of Chronic Illness Therapy-Ascites Index (FACIT-AI) questionnaire, the questionnaire directs to characterise the symptoms associated to ascites regarding 13 factors e.g. appetite, sleep, activities, symptoms, emotional distress by 0 to 4 points. The maximum score is 52 (best result: 13x4), 0 is the minimum score (worst result 13x0)
Incidence of symptoms in the post-paracentesis interval	24 hours after the finish of the paracentesis	Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)
Change of laboratory values	Serial measurements: 2 hours prior to paracentesis, 24 hours after paracentesis	Measurement in plasma (Blood count, creatinin, AST, ALT, urea, aldosterone, renin, sodium, potassium, albumin, C-reactive protein, leukocytes)
Measurement of exact drainage volume	Within 1 hour after the finish of paracentesis	Measurement of exact drainage volume in millilitre
VEGF (vascular endothelial growth factor) level	Within 1 hour after the finish of paracentesis	Measurement of the concentration of hormone vascular endothelial growth factor in ascites
Urine excretion	24 hours after the finish of paracentesis	Urin volume
Change of venous return and mean systemic filling pressure	20 minutes prior to paracentesis, during paracentesis up to the end of paracentesis, an average of 50 minutes	Venous return and mean systemic filling pressure is measured by advanced hemodynamic monitoring

Trial Locations

Locations (1)

Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum; 🇩🇪 Berlin, Germany