Refractory Malignant AscitesNCT02477657
Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
An observational study of Refractory Malignant Ascites, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Malignant Ascites
- What is being tested?
- Paracentesis, Tunneled Intraperitoneal Drain (IPD) and Peritoneal-Venous shunts (PVS)
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2021to Jul 2023
- 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: Adult patients with refractory malignant ascites secondary to GU or GI malignancy.
Who may be able to join
- Refractory malignant ascites defined as ascites requiring more than one paracentesis to control patient symptoms despite medical therapy with diuretics and a. peritoneal fluid with cytology positive for malignant cells OR
- Known malignancy with imaging findings of peritoneal carcinomatosis .
- Eastern Cooperative Oncology Group (ECOG) performance score 3
- Age greater than or equal to 18
- Capable of giving informed consent
Who cannot join
- Life expectancy less than one month
- Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
- Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
- Active skin infections at sites where PVS would be inserted
- Presence of infectious peritonitis or bacteremia
- Neutropenia
Show all 15Show fewer
- American Heart Association Class D congestive heart failure (ie New York Heart Association Class IV)
- Stage 5 CKD (ie GFR < 15 mL/min)
- Severe hypoalbuminemia defined as < 2.2 g/dL
- Loculated or hemorrhagic ascites
- History of bleeding gastroesophageal varices
- Inability to provide informed consent
- Unable to participate in neuropsychological tests / questionnaires
- Pregnant or nursing women
- Anasarca
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.
- Conditions
- Refractory Malignant Ascites
- Being tested
- Paracentesis, Tunneled Intraperitoneal Drain (IPD), Peritoneal-Venous shunts (PVS)
- Keywords
- Adult patients with refractory malignant ascites secondary to GU or GI malignancy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacentesisProcedure or surgery
Paracentesis
Tunneled Intraperitoneal Drain (IPD)Device
Tunneled Intraperitoneal Drain (IPD)
Peritoneal-Venous shunts (PVS)Device
Peritoneal-Venous shunts (PVS)
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJul 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2023 (estimated)
Why it stopped: Industry funding not received. No subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Malignant AscitesStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Nadolski, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477657
- Sponsor's protocol ID
- UPCC 26813
- Status last verified
- Jan 2022
- First submitted
- 16 Jun 2015
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
- ClinicalTrials.gov ID
- NCT02477657
- Acronym / sponsor ID
- UPCC 26813
- Conditions
- Refractory Malignant Ascites
- Keywords
- Adult patients with refractory malignant ascites secondary to GU or GI malignancy.
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Industry funding not received. No subjects enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 23 Jun 2015 (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.
Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with refractory malignant ascites secondary to GU or GI malignancy.
Key inclusion criteria (5 listed)
- Refractory malignant ascites defined as ascites requiring more than one paracentesis to control patient symptoms despite medical therapy with diuretics and a. peritoneal fluid with cytology positive for malignant cells OR
- Known malignancy with imaging findings of peritoneal carcinomatosis .
- Eastern Cooperative Oncology Group (ECOG) performance score 3
- Age greater than or equal to 18
- Capable of giving informed consent
Key exclusion criteria (15 listed)
- Life expectancy less than one month
- Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
- Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
- Active skin infections at sites where PVS would be inserted
- Presence of infectious peritonitis or bacteremia
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 |
|---|---|---|
| ParacentesisParacentesis | Procedure or surgery | – |
| Tunneled Intraperitoneal Drain (IPD)Tunneled Intraperitoneal Drain (IPD) | Device | – |
| Peritoneal-Venous shunts (PVS)Peritoneal-Venous shunts (PVS) | Device | – |
Primary outcome
Number of Adverse Events
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
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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.
Gregory Nadolski, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Malignant Ascites, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2022.