Clinical trial NCT02724683: Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.
Official title: Management of Symptomatic Malignant Ascites With an Patient-controlled, Vascular Catheter - a Validation Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Ascites
Keywords: ascites
drainage
catheter
symptoms
management
quality of life
malignant
cancer
Lead sponsor: Gdynia Oncology Center
Sponsor class: OTHER_GOV
First posted: 2016-03-31
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with adverse events.
timeFrame: 2 weeks
measure: Change in quality of life.
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of participants with drainage complication during cancer treatment vs observation.
timeFrame: 1 month
measure: Number of participants with successful catheter placement.
timeFrame: 2 weeks
measure: Patient's experience on the treatment.
timeFrame: 2 weeks
measure: Change in nutrition habits.
timeFrame: 2 weeks
Other outcomes:
measure: Change in nutrition status among participants with prolonged ascites drainage.
timeFrame: 1 month
measure: Number of ambulatory visits or hospital admissions.
timeFrame: 1 month
Locations:
city: Prague
country: Czechia
facility: The Central and Eastern European Gynecologic Oncology Group (CEEGOG)
city: Gdynia
country: Poland
facility: Gdynia Oncology Center
Study officials:
affiliation: Gdynia Oncology Center
name: Maciej Stukan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.