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

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ClinicalTrials.gov Identifier: NCT04032600
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Klaus Pietzner, 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.

Condition or disease Intervention/treatment Phase
Malignant Ascites Ovarian Cancer Hemodynamic Instability Procedure: Paracentesis Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Malignant Ascites in Ovarian Cancer: Impact of Total Paracentesis on Hemodynamics
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Full paracentesis
All ascites is drained
Procedure: Paracentesis
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
Procedure: Paracentesis
Full versus partial paracentesis (3 liters)




Primary Outcome Measures :
  1. Change of stroke volume [ Time Frame: 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

  2. Change of mean arterial pressure [ Time Frame: 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 :
  1. Incidence of side effects in the post-paracentesis interval [ Time Frame: 24 hours after the finish of the paracentesis ]
    Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)

  2. Incidence of symptoms in the post-paracentesis interval [ Time Frame: 24 hours after the finish of the paracentesis ]
    Incidence of hypotension (medical intervention indicated) and impairment of kidney function (KIDIGO criteria)

  3. Change of stroke volume in the post-paracentesis interval [ Time Frame: 2 hours after the finish of the paracentesis ]
    Stroke volume is measured by advanced hemodynamic monitoring

  4. Change of mean arterial pressure in the post-paracentesis interval [ Time Frame: 2 hours after the finish of the paracentesis ]
    Mean arterial pressure is measured by advanced hemodynamic monitoring

  5. Change of laboratory values [ Time Frame: 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)

  6. Urine excretion [ Time Frame: 24 hours after the finish of paracentesis ]
    Urin volume

  7. Quality of life- pre and post paracentesis: EQ-5D questionnaire [ Time Frame: 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)

  8. Ascites related symptoms- pre and post paracentesis [ Time Frame: 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)

  9. Measurement of exact drainage volume [ Time Frame: Within 1 hour after the finish of paracentesis ]
    Measurement of exact drainage volume in millilitre

  10. VEGF (vascular endothelial growth factor) level [ Time Frame: Within 1 hour after the finish of paracentesis ]
    Measurement of the concentration of hormone vascular endothelial growth factor in ascites

  11. Change of venous return and mean systemic filling pressure [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032600


Contacts
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Contact: Klaus Pietzner, MD +4930350664386 klaus.pietzner@charite.de

Locations
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Germany
Charite-University Medicine of Berlin, Department of Gynecology-Campus Virchow Klinikum Recruiting
Berlin, Germany, 13353
Contact: Klaus Pietzner, MD    +4930450664386    klaus.pietzner@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Klaus Pietzner, MD Charite-University Medicine of Berlin, Department of Gynecology

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Responsible Party: Dr. Klaus Pietzner, Principal Investigator, Consultant of Gynaecological Oncology, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT04032600     History of Changes
Other Study ID Numbers: EA 1/224/16
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Ascites
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes