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

NCT ID: NCT04032600

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-09-09

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.

Conditions

Malignant Ascites; Ovarian Cancer; Hemodynamic Instability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Full paracentesis

All ascites is drained

Group Type: OTHER

Paracentesis

Intervention Type: PROCEDURE

Full versus partial paracentesis (3 liters)

Fractioned paracentesis

3 Liters are drained, then the drain is clamped and the rest of the ascites is drained on the next day

Group Type: OTHER

Paracentesis

Intervention Type: PROCEDURE

Full versus partial paracentesis (3 liters)

Interventions

Paracentesis

Full versus partial paracentesis (3 liters)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed ovarian cancer, peritoneal cancer or fallopian tube cancer
• Symptomatic (e.g. abdominal pressure, pain, shortness of breath) malignant ascites with clinical indication for paracentesis and sonographic estimate of >3 liters
• Patient information and written informed consent

Exclusion Criteria

• Age <18 years
• Missing written informed consent
• Lack of sufficient knowledge of german or english language
• No willingness to consent to the storage or distribution of anonymised disease-specific data inside the clinical trial
• Placement inside a state facility due to judicial order
• Employee status at Charite-University Medicine of Berlin
• Chronic kidney insufficiency defined as serum creatinin levels >1,2 g/dl at time point of admission
• Active neurologic/psychiatric disorder at time point of admission
• Cardiac insufficiency defined as >NYHA I at time point of admission
• Manifest ileus at time point of admission
• Manifest chronic arterial hypo- or hypertension, defined as chronic baseline systolic pressure of <90 or >140 mmHg and diastolic pressure of <70 and >90 mmHg
• Active infection
• Blood clotting disorder (congenital or acquired)
• Thrombocytopenia (platelets <80 000/nl)
• Active participation in another clinical intervention trial at time point of admission
• Chronic atrial fibrillation on time point of admission
• Status post cardiac pacer implantation
• Liver cirrhosis
• Liver metastases

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Dr. Klaus Pietzner

Principal Investigator, Consultant of Gynaecological Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klaus Pietzner, MD

Role: PRINCIPAL_INVESTIGATOR

Charite-University Medicine of Berlin, Department of Gynecology

Locations

Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum

Berlin, , Germany

Countries

Germany

Other Identifiers

EA 1/224/16

Identifier Type: -

Identifier Source: org_study_id