Symptomatic Ascites Drainage With a Patient-controlled Vascular Catheter.

February 22, 2023 updated by: Maciej Stukan, MD, PhD

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

170

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia
        • Recruiting
        • The Central and Eastern European Gynecologic Oncology Group (CEEGOG)
        • Contact:
          • Ivana Nohova
        • Contact:
  • Poland
      • Gdynia, Poland, 81-519

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 month
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.
2 weeks
Patient's experience on the treatment.
Time Frame: 2 weeks
Patient's experience on the treatment measured with standard questionnaire (FACIT-TS-G).
2 weeks
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.
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month
Number of ambulatory visits or hospital admissions.
Time Frame: 1 month
Number of ambulatory visits or hospital admissions to manage symptoms caused by ascites.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maciej Stukan, MD, PhD

Investigators

  • Principal Investigator: Maciej Stukan, MD, Gdynia Oncology Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

March 20, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 31, 2016

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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