Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.
NCT ID: NCT02724683
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
170 participants
OBSERVATIONAL
2016-01-31
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
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.
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.
Quality of procedure.
Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure.
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.
Interventions
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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.
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.
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.
Quality of procedure.
Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure.
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.
Eligibility Criteria
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Inclusion Criteria
* supportive care (professional or family members) available at patients' home,
* informed signed consent of the patient.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Maciej Stukan, MD, PhD
OTHER_GOV
Responsible Party
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Maciej Stukan, MD, PhD
Dr
Principal Investigators
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Maciej Stukan, MD
Role: PRINCIPAL_INVESTIGATOR
Gdynia Oncology Center
Locations
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The Central and Eastern European Gynecologic Oncology Group (CEEGOG)
Prague, , Czechia
Gdynia Oncology Center
Gdynia, , Poland
Countries
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Central Contacts
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Facility Contacts
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Ivana Nohova
Role: primary
Role: backup
References
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Hui D, Bruera E. Integrating palliative care into the trajectory of cancer care. Nat Rev Clin Oncol. 2016 Mar;13(3):159-71. doi: 10.1038/nrclinonc.2015.201. Epub 2015 Nov 24.
Stephenson J, Gilbert J. The development of clinical guidelines on paracentesis for ascites related to malignancy. Palliat Med. 2002 May;16(3):213-8. doi: 10.1191/0269216302pm509oa.
Becker G, Galandi D, Blum HE. Malignant ascites: systematic review and guideline for treatment. Eur J Cancer. 2006 Mar;42(5):589-97. doi: 10.1016/j.ejca.2005.11.018. Epub 2006 Jan 24.
Stukan M, Lesniewski-Kmak K, Wroblewska M, Dudziak M. Management of symptomatic ascites and post-operative lymphocysts with an easy-to-use, patient-controlled, vascular catheter. Gynecol Oncol. 2015 Mar;136(3):466-71. doi: 10.1016/j.ygyno.2014.11.073. Epub 2014 Nov 28.
da Silva Fink J, Daniel de Mello P, Daniel de Mello E. Subjective global assessment of nutritional status - A systematic review of the literature. Clin Nutr. 2015 Oct;34(5):785-92. doi: 10.1016/j.clnu.2014.12.014. Epub 2014 Dec 26.
Stukan M. Drainage of malignant ascites: patient selection and perspectives. Cancer Manag Res. 2017 Apr 12;9:115-130. doi: 10.2147/CMAR.S100210. eCollection 2017.
Other Identifiers
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GCO-1
Identifier Type: -
Identifier Source: org_study_id
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