20 Participants NeededMy employer runs this trial

At-home Paracentesis for Malignant Ascites

(Paracentesis Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Utah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe changes in symptoms when women with cancer-related fluid buildup in the abdomen (malignant ascites) perform paracentesis at home. Paracentesis involves draining excess fluid from the abdomen to relieve discomfort. Women who have undergone a similar procedure in a clinic and experience symptoms from this fluid buildup might be suitable candidates for the trial. The study seeks to determine if performing the procedure at home can effectively ease symptoms. As an unphased trial, it offers participants the chance to contribute to research that could enhance home-based care for others in the future.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulant therapy (blood thinners), you may need to pause it before the procedure, depending on the investigator's opinion.

What prior data suggests that this at-home paracentesis is safe for women with malignant ascites?

Research has shown that performing paracentesis at home safely manages malignant ascites, a condition where fluid accumulates in the abdomen due to cancer. Studies have found that patients handle this procedure well in a home setting.

For example, several studies have found that home-based paracentesis is not only safe but also effective and convenient for patients requiring comfort care. One study noted that patients could undergo this procedure safely and effectively without hospital visits. Another study confirmed that this method works well for those with recurring fluid buildup.

Overall, evidence suggests that at-home paracentesis is a reliable and safe treatment option for managing malignant ascites.12345

Why are researchers excited about this trial?

Researchers are excited about at-home paracentesis for malignant ascites because it offers a new level of convenience and comfort for patients. Unlike traditional paracentesis, which requires hospital visits, this method allows the procedure to be performed at home, reducing the need for frequent hospital trips and potentially lowering healthcare costs. This new approach could significantly improve the quality of life for patients by minimizing travel and wait times, making it a promising alternative to standard care.

What evidence suggests that at-home paracentesis is effective for malignant ascites?

Research has shown that performing paracentesis at home effectively manages malignant ascites, a condition where fluid accumulates in the abdomen due to cancer. One study found that draining this fluid at home is safe and helps many patients manage their symptoms easily. Another study concluded that this method is not only safe but also a cost-effective way to relieve discomfort. In 64% to 100% of cases, patients experienced symptom relief, meaning most felt better. Additionally, even small amounts of fluid removal at home can significantly reduce abdominal swelling in terminally ill cancer patients. Overall, the evidence supports at-home paracentesis as a promising option for managing symptoms in patients with malignant ascites.12367

Who Is on the Research Team?

AB

Anna Beck, MD

Principal Investigator

Huntsman Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with cancer who have fluid buildup in the abdomen (malignant ascites) causing symptoms. They must have already had a clinic-based paracentesis, be able to pause blood thinners if needed, and can safely do the procedure at home. Women with certain medical issues or unsafe home environments cannot join.

Inclusion Criteria

For participants of child-bearing potential, participant is following standard of care guidelines for contraception
I can safely pause my blood thinner medication before the procedure.
Eligible to receive an ultrasound-guided paracentesis procedure at home in the opinion of the investigator
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Exclusion Criteria

Large ventral hernias or prior complications from paracentesis
My health is not rapidly getting worse and I do not have a suspected bowel blockage.
Any condition that would, in the Investigator's judgment, contraindicate the participant's participation in the procedure or clinical study due to safety concerns or compliance with clinical study procedures. For example, medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an at-home-based paracentesis procedure

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • At-home Paracentesis

Trial Overview

The study tests whether doing paracentesis—a procedure to drain abdominal fluid—at home helps improve symptoms for women with cancer-related ascites. Participants will receive ultrasound-guided paracentesis at their homes.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: At-home ParacentesisExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28350743/

Home-based drainage of refractory ascites by a permanent ...

The number of paracentesis decreased from 2.2±1 to 0 per week, although the volume of daily ascites removal remained stable (2 l). Despite frequent drainage of ...

Palliative Paracentesis in the Home Setting

This study found that home-based palliative paracentesis is a safe, effective, and convenient intervention for hospice and palliative care patients with ...

Home‐based, tunnelled peritoneal drainage system as an ...

Home-based, tunnelled peritoneal catheters (PeCa) have been suggested as an alternative treatment option. However, data on patients with cirrhosis are scarce.

Managing malignant ascites at home

We conclude that repeated abdominal paracentesis in the home is safe, cost-effective and an appropriate strategy for the management of recurrent ...

Drainage of malignant ascites: patient selection and ... - PMC

Efficacy defined with symptom control was achieved in 64%–100%, generally for all methods. Patients with MA who benefit from drainage the most are those who ...

143 Nurse led paracentesis for palliative care patients in ...

Conclusion Nurse led home-based palliative paracentesis is a safe, effective, and convenient intervention for hospice and palliative care patients with ...

Palliative Paracentesis in the Home Setting: A Case Series

Results: Thirty-three patients were referred for HBPP for symptomatic abdominal distention from March 1, 2019 to March 1, 2020. Thirty (91%) ...