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Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

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ClinicalTrials.gov Identifier: NCT02724683
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Maciej Stukan, MD, PhD, Gdynia Oncology Center

Brief Summary:
The purpose of this study is to determine whether drainage with the usage of a fine, patient-controlled vascular catheter inserted into abdominal cavity is a feasible, safe and effective method in the management of symptomatic malignant ascites. Complications' rate of the procedure and patients' quality of life, nutritional status and experience on the treatment are main endpoints.

Condition or disease Intervention/treatment
Malignant Ascites Device: Ascites drainage with vascular catheter. Behavioral: Interview. Behavioral: Quality of life. Device: Quality of procedure. Other: Nutritional status

Detailed Description:

Patients with symptomatic, refractory malignant ascites (MA) will be eligible for the study. In case a cancer treatment is not effective against ascites, or no target, systemic treatment is possible patients will be eligible for percutaneous placement of a vascular catheter into abdominal cavity followed be drainage performed in a regular basis when required, at home or ambulatory. Adult patients with every malignant disease, female and male, and coexisting symptomatic MA can be recruited.

Clinical, quality of life (QOL) and quality of the procedure data will be collected. The study is planned to be a multiinstitutional. A template is provided to collect essential clinical data concerned with a patient, malignant disease, procedure performance and complications. QOL and patients' experience on the treatment is to be evaluated with formal questionnaires - EORTC C15-PAL and FACIT-TS-G - permission to use granted from EORTC and FACIT respectively. Additionally, a nutrition monitoring will be performed (if possible and feasible) in patients with MA and drainage.

Data will be saved in a computer, secured data base for calculations. A cohort of 150 patients is planned to be collected. Duration of the study will depend on how many institutions will participate, and how fast patients will be recruited.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Management of Symptomatic Malignant Ascites With an Patient-controlled, Vascular Catheter - a Validation Study.
Study Start Date : January 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Group/Cohort Intervention/treatment
Symptomatic ascites drainage with CVC.
Patients with malignant, symptomatic, refractory ascites. Ascites drainage with vascular catheter (CVC) inserted into abdominal cavity will be performed. Patients will be asked to complete interview, quality of life questionnaire, nutritional status assessment and quality of procedure survey.
Device: Ascites drainage with vascular catheter.
In case of symptomatic malignant ascites, the procedure of vascular catheter insertion into abdominal cavity will be performed, followed by slow, systematic drainage, on patient's demand.

Behavioral: Interview.
Interview with patients will be performed according to attached chart. The aim is to collect data concerning patient's symptoms, co-morbidity, and basic clinical data about the primary malignancy and treatment status.

Behavioral: Quality of life.
Quality of life questionnaire (QLQ). Patients will be asked to complete QLQ at two time points: 1. immediately before the procedure, 2. one or two weeks after the procedure.

Device: Quality of procedure.
Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure.

Other: Nutritional status
Risk of malnutrition and ability to feed normally will be assessed with specific questionnaire at two time points: 1. immediately before the procedure, 2. one or two weeks after the procedure.




Primary Outcome Measures :
  1. Number of participants with adverse events. [ Time Frame: 2 weeks ]
    Early and late adverse events of the catheter placement and later drainage to be recorded.

  2. Change in quality of life. [ Time Frame: 2 weeks ]
    Change in quality of life measured with standard questionnaire EORTC-C15-PAL before the procedure and 1-2 weeks later.


Secondary Outcome Measures :
  1. Number of participants with drainage complication during cancer treatment vs observation. [ Time Frame: 1 month ]
    Assessment of possibilities to provide cancer treatment with active ascites drainage via catheter, by reporting number of participants with adverse events during chemotherapy or radiotherapy, whichever applies and comparison to observation (patients with palliative intent only, no active cancer treatment).

  2. Number of participants with successful catheter placement. [ Time Frame: 2 weeks ]
    From all eligible participants a number of participants with successful catheter placement followed by effective drainage will be recorded.

  3. Patient's experience on the treatment. [ Time Frame: 2 weeks ]
    Patient's experience on the treatment measured with standard questionnaire (FACIT-TS-G).

  4. Change in nutrition habits. [ Time Frame: 2 weeks ]
    Changes in ability to feed assessed in a descriptive way with the Subjective Global Assessment (SGA) questionnaire.


Other Outcome Measures:
  1. Change in nutrition status among participants with prolonged ascites drainage. [ Time Frame: 1 month ]
    Risk of malnutrition and ability to feed normally to be assessed with Subjective Global Assessment (SGA) questionnaire among participants with prolonged (1-2 months) ascites drainage.

  2. Number of ambulatory visits or hospital admissions. [ Time Frame: 1 month ]
    Number of ambulatory visits or hospital admissions to manage symptoms caused by ascites.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients considered eligible are those with malignant disease of any origin and coexisting symptomatic ascites who require a management anyway.
Criteria

Inclusion Criteria:

  • patients with symptomatic, refractory malignant ascites,
  • supportive care (professional or family members) available at patients' home,
  • informed signed consent of the patient.

Exclusion Criteria:

  • ascites not of malignant origin,
  • asymptomatic ascites,
  • suspected or clinically apparent infection especially at the site of planned drainage placement,
  • significant coagulopathy,
  • very poor performance status (PS4),
  • patient not able to read and sign informed consent,
  • mucinous ascites.

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): NCT02724683


Contacts
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Contact: Maciej Stukan, MD +48692112481 mstukan@szpital-morski.pl

Locations
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Poland
Gdynia Oncology Center Recruiting
Gdynia, Poland, 81-519
Contact: Maciej Stukan, MD    +48692112481    mstukan@szpital-morski.pl   
Sponsors and Collaborators
Maciej Stukan, MD, PhD
Investigators
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Principal Investigator: Maciej Stukan, MD Gdynia Oncology Center

Additional Information:

Publications of Results:
Other Publications:
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Responsible Party: Maciej Stukan, MD, PhD, Dr, Gdynia Oncology Center
ClinicalTrials.gov Identifier: NCT02724683     History of Changes
Other Study ID Numbers: GCO-1
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Maciej Stukan, MD, PhD, Gdynia Oncology Center:
ascites
drainage
catheter
symptoms
management
quality of life
malignant
cancer

Additional relevant MeSH terms:
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Ascites
Pathologic Processes