Malignant AscitesNCT02724683
Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.
An observational study of Malignant Ascites, run by Maciej Stukan, MD, PhD at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Ascites
- What is being tested?
- Ascites drainage with vascular catheter., Interview. and Quality of life.
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 170 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2016to Dec 2023
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients considered eligible are those with malignant disease of any origin and coexisting symptomatic ascites who require a management anyway.
Who may be able to join
- patients with symptomatic, refractory malignant ascites,
- supportive care (professional or family members) available at patients' home,
- informed signed consent of the patient.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Czechia1 site, 1 recruiting
- Recruiting
The Central and Eastern European Gynecologic Oncology Group (CEEGOG)
Prague
Ivana Nohova
ceegog@ceegog.eu
Poland1 site, 1 recruiting
- Recruiting
Gdynia Oncology Center
Gdynia, 81-519
Maciej Stukan, MD, +48692112481, mstukan@szpitalepomorskie.eu
About this study
Official title: Management of Symptomatic Malignant Ascites With an Patient-controlled, Vascular Catheter - a Validation Study.
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.
Read the 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.
- Conditions
- Malignant Ascites
- Being tested
- Ascites drainage with vascular catheter., Interview., Quality of life., Quality of procedure., Nutritional status
- Keywords
- ascites, drainage, catheter, symptoms, management, quality of life, malignant, cancer
- Medical subject headings
- Ascites, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascites drainage with vascular catheter.Device
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.Behavioural
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.Behavioural
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.Device
Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure.
Nutritional statusOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ascites drainage with vascular catheter.; Behavioral: Interview.; Behavioral: Quality of life.; Device: Quality of procedure.; Other: Nutritional status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events.
Early and late adverse events of the catheter placement and later drainage to be recorded.
Measured: 2 weeks
Change in quality of life.
Change in quality of life measured with standard questionnaire EORTC-C15-PAL before the procedure and 1-2 weeks later.
Measured: 2 weeks
Secondary outcomes (4)
Number of participants with drainage complication during cancer treatment vs observation.
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).
Measured: 1 month
Number of participants with successful catheter placement.
From all eligible participants a number of participants with successful catheter placement followed by effective drainage will be recorded.
Measured: 2 weeks
Patient's experience on the treatment.
Patient's experience on the treatment measured with standard questionnaire (FACIT-TS-G).
Measured: 2 weeks
Change in nutrition habits.
Changes in ability to feed assessed in a descriptive way with the Subjective Global Assessment (SGA) questionnaire.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malignant AscitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Maciej Stukan, MD, PhD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Maciej Stukan, MD, PhD, Gdynia Oncology Center
- Investigators
- Maciej Stukan, MD, Principal investigator, Gdynia Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724683
- Sponsor's protocol ID
- GCO-1
- Status last verified
- Feb 2023
- First submitted
- 20 Mar 2016
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26598947Stephenson 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.
PubMed 12046997Becker 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.
PubMed 16434188Stukan 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.
PubMed 25434633da 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.
PubMed 25596153Stukan 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.
PubMed 28442933
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Symptomatic Malignant Ascites With an Patient-controlled, Vascular Catheter - a Validation Study.
- ClinicalTrials.gov ID
- NCT02724683
- Acronym / sponsor ID
- GCO-1
- Conditions
- Malignant Ascites
- Keywords
- ascites, drainage, catheter, symptoms, management, quality of life, malignant, cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Maciej Stukan, MD, PhDOther government
- Study start
- Jan 2016
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Symptomatic ascites drainage with CVC. | – | Device: Ascites drainage with vascular catheter., Behavioral: Interview., Behavioral: Quality of life., Device: Quality of procedure., Other: Nutritional statusPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients considered eligible are those with malignant disease of any origin and coexisting symptomatic ascites who require a management anyway.
Key inclusion criteria (3 listed)
- patients with symptomatic, refractory malignant ascites,
- supportive care (professional or family members) available at patients' home,
- informed signed consent of the patient.
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Symptomatic ascites drainage with CVC. |
| 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. | Behavioural | Symptomatic ascites drainage with CVC. |
| 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. | Behavioural | Symptomatic ascites drainage with CVC. |
| Quality of procedure.Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure. | Device | Symptomatic ascites drainage with CVC. |
| Nutritional statusRisk 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. | Other | Symptomatic ascites drainage with CVC. |
Primary outcome
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.
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.
4 secondary outcomes
Number of participants with drainage complication during cancer treatment vs observation.
Time frame: 1 month
Number of participants with successful catheter placement.
Time frame: 2 weeks
Patient's experience on the treatment.
Time frame: 2 weeks
Change in nutrition habits.
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 26598947Hui 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.
- Results publication: PubMed 12046997Stephenson 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.
- Results publication: PubMed 16434188Becker 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.
- Results publication: PubMed 25434633Stukan 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.
- Results publication: PubMed 25596153da 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.
- Results publication: PubMed 28442933Stukan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maciej Stukan, MD principal investigator
Gdynia Oncology Center
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Ascites, run by Maciej Stukan, MD, PhD at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maciej Stukan, MD (+48692112481, mstukan@szpital-morski.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events. (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02724683, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.