Ascites, MalignantNCT03550690
Quality of Life of Patients Who Have Rocket Indwelling Pleural Catheter Drainage or Repeated Large Volume Paracentesis
An observational study of Ascites, Malignant, run by Gloucestershire Hospitals NHS Foundation Trust.
Trial summary
Ascites (accumulation of fluid in the abdominal cavity) is a common problem which can lead to distressing symptoms. When caused by cancer, management options are chemotherapy, diuretics and ascitic drainage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites, Malignant
- What is being tested?
- Large Volume Paracentesis and Rocket Indwelling Pleural Catheter
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2018to Jul 2019
- How long will I take part?
- 3 Months
- 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: See above
Patient Inclusion Criteria:
- Male or female adult patients
- Have ascites due to cancer undergoing treatment at Gloucestershire Hospitals NHS Foundation Trust
- Planned to have an ascitic tap within a week
- Thought to have an estimated prognosis of 12 weeks or more
- Willing and able to provide signed written informed consent
Patient Exclusion Criteria
- Patients who, in the opinion of the clinical team, would be too distressed by the idea of participation.
- Patients who might not adequately understand verbal explanations or written information given in English.
Relative Inclusion Criteria:
- Adult supporting patient participant in Rocket Project 1
- Happy to support patient with completion of patient diaries
Relative Exclusion Criteria
- Relatives who, in the opinion of the clinical team, would be too distressed by the idea of participation.
- Relatives who might not adequately understand verbal explanations or written information given in English.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Quality of Life of Patients Who Have Rocket Indwelling Pleural Catheter Drainage or Repeated Large Volume Paracentesis - Observational Feasibility Study
Ascites (accumulation of fluid in the abdominal cavity) is a common problem which can lead to distressing symptoms. When caused by cancer, management options are chemotherapy, diuretics and ascitic drainage. Ascitic drainage is performed by inserting a plastic tube into the abdomen and draining off the fluid under local anaesthetic, removing the drain afterwards. For some, the fluid will return and the procedure needs repeating. A relatively new treatment involves inserting a semi-permanent drain - a small plastic tube under the skin which is left in place so that the fluid can be drained if it builds up again. The potential benefit to patients is that afterwards they can have fluid removed at home. This might reduce the number of hospital admissions, outpatient visits and the number of procedures they need to have in the last few months of life. In Gloucestershire, the Rocket Indwelling Pleural Catheter (IPC) is the semi-permanent drain of choice.
Our research group has a particular interest in the management of ascites and we recently completed the first qualitative interview study with patients with this condition - patients with ascites secondary to cancer. Patients were pleased to have semi-permanent drains in place as it meant that repeated admissions to hospital were avoided. They did not have to wait for a build-up of fluid before more could be drained off; and symptoms never had to build up as badly as when they were having repeated ascitic drainage.
We plan a feasibility study to ascertain whether a definitive non-randomised study to detect differences in quality of life between Rocket IPC and repeat ascitic drainage is possible and how many patients would be needed for such a study.
Read the detailed description
Study Objective This feasibility study aims to establish how best to conduct a definitive prospective non-randomised QOL study for patients with malignant ascites who either have placement of a Rocket IPC or repeated LVP
Study Design This is an open label, non-randomised observational study. Each patient will receive verbal and written information followed by signing of an Informed Consent Form prior to participation. They will be asked to capture data about their QOL by completing paper diaries.
If the patient has a relative / next of kin we will ask permission from the patient to approach them to see if they would be happy to consent to helping with data collection for the study.
Study Procedures
When patients are booked for ascitic drainage in hospitals or hospice a member of the patient's clinical team will discuss the study with the patient (either in person or via telephone). If in agreement, the doctor / nurse will pass on their contact details to a member of the research team who will then telephone the patient and:
- Ask the patient if they would be happy to receive a patient information leaflet by post or email
- Ask the patient if they would be happy for their relative / next of kin to be contacted about this study. The relative / next of kin will then be contacted and, if they are happy to receive it, a participant information leaflet will be posted or emailed to them.
[If the patient is having an IPC fitted the relative may fit the inclusion criteria for the related study, Rocket Project 2, so that this study may be discussed at this point and a participant information leaflet provided too.]
At the time of admission for the procedure informed consent will be obtained from the patient and the following information will be obtained and recorded on a case report form:
- Patient's age, gender, diagnosis
- Performance status
- How many LVPs the patient has had up until the current procedure
- Patient's understanding of treatment options for ascites management, in particular whether Rocket IPC has been mentioned
- Why was this option chosen?
- Opinion about participation in a randomised trial if one was being conducted The research nurse will ensure that baseline blood tests to include renal function and albumin have been performed prior to the procedure.
Rarely, a patient could be referred for the procedure and have it performed later that day. In that scenario we would like to have permission for a cooling off period to be waived by the participants - we would argue that this is not a particularly burdensome study.
Informed consent will also be sought from the relative / next of kin. It will usually be possible to do obtain this when the patient attends for the procedure but a separate appointment to obtain informed consent may be needed at the relative / next of kin's home or care setting.
A patient can be recruited to the study if their relative / next of kin does not consent OR they have no relative / next of kin.
A four week diary will be given to the patient to capture the following information:
- Number of LVPs / Rocket IPC drainage episodes performed*
- Volumes of fluid removed at LVPs OR number of Rocket IPC bottles used at Rocket IPC drainage*
- Any complications - catheter blockage, infections, hospital admissions*
- The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM) DAILY
- The EuroQol questionnaire (EQ-5D) as a generic QOL measure DAILY
- The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL Questionnaire (QLQ-C30) WEEKLY
- Anti-cancer treatment received by the patient*
- Diuretics received by the patient*
If a relative / next of kin has consented they can help the patient to complete their diary. They will not be able to give a proxy measure for any of the quality of life scores but will be able to assist the patient with completion of these and also with objective measures (e.g. those marked * above) The research nurse will contact the patient frequently by phone, to provide support with data collection, if required.
When the patient is close to completing 4 weeks in the study they will be offered the opportunity to complete another 4 week diary. It will be explained to them that this is not essential but will provide useful information.
When close to completing the 2nd 4 week diary (i.e. after 8 weeks) they will, once again, be offered a further diary. Patients will complete a maximum of three diaries.
Patients will not be expected to complete questionnaires if they do not feel well enough or lose capacity. Patients' clinical course can fluctuate and there may be a time when they feel well enough to complete questionnaires again. Data about fluid volumes removed may still be collected after a patient loses capacity by healthcare staff, as is routine practice, or consenting relatives / next of kin.
Only patients with capacity will be approached for participation in the study.
Blood Tests Renal function and albumin will be measured at baseline, 6 weeks and 12 weeks (the latter 2 time points only if the patient remains in the study after 4 weeks and 8 weeks) - if necessary performed by the research nurse at patient's home.
Blood tests will not be performed on patients who have lost capacity for the purposes of this study. If patients without capacity have blood tests taken for other reasons the results will be used as part of data analysis.
Only a very small percentage of people living in Gloucestershire are not English speaking. It has been decided that it is not cost effective to fund translation for this feasibility study. The information on the numbers of patients / carers who may have been excluded and the languages that might have been needed will be collected and this will be taken into account when planning a larger study.
Outcome measures
There have been recommendations about suitable QOL measures for use with patients with ascites. We discussed these with service users and carers and have agreed on using for this study:
- The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM)
- The EuroQol questionnaire (EQ-5D) as a generic QOL measure
- The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL Questionnaire (QLQ-C30)
In addition we will ask healthcare professionals, patients or consenting carers (depending on who manages the drain) to record volumes of fluid removed at each paracentesis and episode of semi-permanent drainage.
We will ask patients and carers about:
Drainage complications and hospital admissions. Chemotherapy use Diuretic use
Withdrawal of subjects from the study
Patients will cease participation in the study when one of the following criteria is met:
They choose to withdraw They choose not to complete a further QOL diary They complete their third monthly QOL diary They lose capacity and it is thought that this will be permanent
Carers will cease participation in the study when one of the following criteria is met:
They choose to withdraw The patient dies
A patient may remain in the study although a carer / next of kin has withdrawn and vice versa.
Statistical Analysis Percentage presence and percentage completeness of the three QOL measures will be evaluated. These results will allow an estimation of the number of patients, resources and time needed to perform a definitive prospective non-randomised QOL study for patients with malignant ascites who either have placement of a Rocket IPC or repeated LVP.
The following analysis will also be conducted:
- QLQ-C30 and EQ-5D averaged for each participant for the duration of their participation, using the area under the curve method.
- ESAS:AM analysed by estimating the prevalence of individual symptoms at each time point, as well as the time-weighted average burden of symptoms for each participant.
It is hoped that data from the feasibility study can be used in the definitive study if the methodology of the two studies remains the same.
We estimate over a 6-month period approximately 60 patients with ascites secondary to cancer will have a paracentesis. We plan to recruit 20 patients having a drainage procedure (LVP or Rocket IPC) within 6 months.
- Conditions
- Ascites, Malignant
- Being tested
- Large Volume Paracentesis, Rocket Indwelling Pleural Catheter
- Medical subject headings
- Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Large Volume ParacentesisDevice
Insertion of a plastic tube into the abdomen and draining off ascitic fluid under local anaesthetic, removing the drain afterwards
Rocket Indwelling Pleural CatheterDevice
A small plastic tube under the skin which is left in place so that the fluid can be drained if it builds up again
| Study group | Role | What they receive |
|---|---|---|
| Large Volume Paracentesis | Patient has repeated large volume paracentesis for recurrent ascites secondary to cancer Receives: Device: Large Volume Paracentesis | |
| Semi-permanent drain | Patient has a semi-permanent drain (Rocket Indwelling Pleural Catheter) placed for recurrent ascites secondary to cancer Receives: Device: Rocket Indwelling Pleural Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage presence and percentage completeness of the three QOL measures
Measured: 3 months
Secondary outcomes (8)
Number of LVPs / Rocket IPC drainage episodes performed
Measured: 3 months
Volumes of fluid removed at LVPs OR number of Rocket IPC bottles used at Rocket IPC drainage
Measured: 3 months
Complications
Catheter blockage, infections, hospital admissions
Measured: 3 months
The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM) DAILY
Measured: 3 months
The EuroQol questionnaire (EQ-5D) as a generic QOL measure DAILY
Measured: 3 months
The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL Questionnaire (QLQ-C30) WEEKLY
Measured: 3 months
Anti-cancer treatment received by the patient
Measured: 3 months
Diuretics received by the patient
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study startSep 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ascites, MalignantStudies 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
- 20 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Perkins, Gloucestershire Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550690
- Sponsor's protocol ID
- Rocket Project 1
- Other IDs
- 242415
- Status last verified
- Jun 2018
- First submitted
- 26 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available on request
Publications
Day R, Mitchell T, Keen A, Perkins P. The experiences of patients with ascites secondary to cancer: a qualitative study. Palliat Med. 2013 Sep;27(8):739-46. doi: 10.1177/0269216313480400. Epub 2013 Apr 4.
PubMed 23558342Easson AM, Bezjak A, Ross S, Wright JG. The ability of existing questionnaires to measure symptom change after paracentesis for symptomatic ascites. Ann Surg Oncol. 2007 Aug;14(8):2348-57. doi: 10.1245/s10434-007-9370-3. Epub 2007 May 16.
PubMed 17505860
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quality of Life of Patients Who Have Rocket Indwelling Pleural Catheter Drainage or Repeated Large Volume Paracentesis - Observational Feasibility Study
- ClinicalTrials.gov ID
- NCT03550690
- Acronym / sponsor ID
- Rocket Project 1
- Conditions
- Ascites, Malignant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gloucestershire Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 8 Jun 2018 (actual)
- 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.
Ascites (accumulation of fluid in the abdominal cavity) is a common problem which can lead to distressing symptoms. When caused by cancer, management options are chemotherapy, diuretics and ascitic drainage. Ascitic drainage is performed by inserting a plastic tube into the abdomen and draining off the fluid under local anaesthetic, removing the drain afterwards. For some, the fluid will return and the procedure needs repeating. A relatively new treatment involves inserting a semi-permanent drain - a small plastic tube under the skin which is left in place so that the fluid can be drained if it builds up again. The potential benefit to patients is that afterwards they can have fluid removed at home. This might reduce the number of hospital admissions, outpatient visits and the number of procedures they need to have in the last few months of life. In Gloucestershire, the Rocket Indwelling Pleural Catheter (IPC) is the semi-permanent drain of choice.
Our research group has a particular interest in the management of ascites and we recently completed the first qualitative interview study with patients with this condition - patients with ascites secondary to cancer. Patients were pleased to have semi-permanent drains in place as it meant that repeated admissions to hospital were avoided. They did not have to wait for a build-up of fluid before more could be drained off; and symptoms never had to build up as badly as when they were having repeated ascitic drainage.
We plan a feasibility study to ascertain whether a definitive non-randomised study to detect differences in quality of life between Rocket IPC and repeat ascitic drainage is possible and how many patients would be needed for such a study.
Detailed description
Study Objective This feasibility study aims to establish how best to conduct a definitive prospective non-randomised QOL study for patients with malignant ascites who either have placement of a Rocket IPC or repeated LVP
Study Design This is an open label, non-randomised observational study. Each patient will receive verbal and written information followed by signing of an Informed Consent Form prior to participation. They will be asked to capture data about their QOL by completing paper diaries.
If the patient has a relative / next of kin we will ask permission from the patient to approach them to see if they would be happy to consent to helping with data collection for the study.
Study Procedures
When patients are booked for ascitic drainage in hospitals or hospice a member of the patient's clinical team will discuss the study with the patient (either in person or via telephone). If in agreement, the doctor / nurse will pass on their contact details to a member of the research team who will then telephone the patient and:
- Ask the patient if they would be happy to receive a patient information leaflet by post or email
- Ask the patient if they would be happy for their relative / next of kin to be contacted about this study. The relative / next of kin will then be contacted and, if they are happy to receive it, a participant information leaflet will be posted or emailed to them.
[If the patient is having an IPC fitted the relative may fit the inclusion criteria for the related study, Rocket Project 2, so that this study may be discussed at this point and a participant information leaflet provided too.]
At the time of admission for the procedure informed consent will be obtained from the patient and the following information will be obtained and recorded on a case report form:
- Patient's age, gender, diagnosis
- Performance status
- How many LVPs the patient has had up until the current procedure
- Patient's understanding of treatment options for ascites management, in particular whether Rocket IPC has been mentioned
- Why was this option chosen?
- Opinion about participation in a randomised trial if one was being conducted The research nurse will ensure that baseline blood tests to include renal function and albumin have been performed prior to the procedure.
Rarely, a patient could be referred for the procedure and have it performed later that day. In that scenario we would like to have permission for a cooling off period to be waived by the participants - we would argue that this is not a particularly burdensome study.
Informed consent will also be sought from the relative / next of kin. It will usually be possible to do obtain this when the patient attends for the procedure but a separate appointment to obtain informed consent may be needed at the relative / next of kin's home or care setting.
A patient can be recruited to the study if their relative / next of kin does not consent OR they have no relative / next of kin.
A four week diary will be given to the patient to capture the following information:
- Number of LVPs / Rocket IPC drainage episodes performed*
- Volumes of fluid removed at LVPs OR number of Rocket IPC bottles used at Rocket IPC drainage*
- Any complications - catheter blockage, infections, hospital admissions*
- The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM) DAILY
- The EuroQol questionnaire (EQ-5D) as a generic QOL measure DAILY
- The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL Questionnaire (QLQ-C30) WEEKLY
- Anti-cancer treatment received by the patient*
- Diuretics received by the patient*
If a relative / next of kin has consented they can help the patient to complete their diary. They will not be able to give a proxy measure for any of the quality of life scores but will be able to assist the patient with completion of these and also with objective measures (e.g. those marked * above) The research nurse will contact the patient frequently by phone, to provide support with data collection, if required.
When the patient is close to completing 4 weeks in the study they will be offered the opportunity to complete another 4 week diary. It will be explained to them that this is not essential but will provide useful information.
When close to completing the 2nd 4 week diary (i.e. after 8 weeks) they will, once again, be offered a further diary. Patients will complete a maximum of three diaries.
Patients will not be expected to complete questionnaires if they do not feel well enough or lose capacity. Patients' clinical course can fluctuate and there may be a time when they feel well enough to complete questionnaires again. Data about fluid volumes removed may still be collected after a patient loses capacity by healthcare staff, as is routine practice, or consenting relatives / next of kin.
Only patients with capacity will be approached for participation in the study.
Blood Tests Renal function and albumin will be measured at baseline, 6 weeks and 12 weeks (the latter 2 time points only if the patient remains in the study after 4 weeks and 8 weeks) - if necessary performed by the research nurse at patient's home.
Blood tests will not be performed on patients who have lost capacity for the purposes of this study. If patients without capacity have blood tests taken for other reasons the results will be used as part of data analysis.
Only a very small percentage of people living in Gloucestershire are not English speaking. It has been decided that it is not cost effective to fund translation for this feasibility study. The information on the numbers of patients / carers who may have been excluded and the languages that might have been needed will be collected and this will be taken into account when planning a larger study.
Outcome measures
There have been recommendations about suitable QOL measures for use with patients with ascites. We discussed these with service users and carers and have agreed on using for this study:
- The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM)
- The EuroQol questionnaire (EQ-5D) as a generic QOL measure
- The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL Questionnaire (QLQ-C30)
In addition we will ask healthcare professionals, patients or consenting carers (depending on who manages the drain) to record volumes of fluid removed at each paracentesis and episode of semi-permanent drainage.
We will ask patients and carers about:
Drainage complications and hospital admissions. Chemotherapy use Diuretic use
Withdrawal of subjects from the study
Patients will cease participation in the study when one of the following criteria is met:
They choose to withdraw They choose not to complete a further QOL diary They complete their third monthly QOL diary They lose capacity and it is thought that this will be permanent
Carers will cease participation in the study when one of the following criteria is met:
They choose to withdraw The patient dies
A patient may remain in the study although a carer / next of kin has withdrawn and vice versa.
Statistical Analysis Percentage presence and percentage completeness of the three QOL measures will be evaluated. These results will allow an estimation of the number of patients, resources and time needed to perform a definitive prospective non-randomised QOL study for patients with malignant ascites who either have placement of a Rocket IPC or repeated LVP.
The following analysis will also be conducted:
- QLQ-C30 and EQ-5D averaged for each participant for the duration of their participation, using the area under the curve method.
- ESAS:AM analysed by estimating the prevalence of individual symptoms at each time point, as well as the time-weighted average burden of symptoms for each participant.
It is hoped that data from the feasibility study can be used in the definitive study if the methodology of the two studies remains the same.
We estimate over a 6-month period approximately 60 patients with ascites secondary to cancer will have a paracentesis. We plan to recruit 20 patients having a drainage procedure (LVP or Rocket IPC) within 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large Volume Paracentesis | – | Device: Large Volume ParacentesisPatient has repeated large volume paracentesis for recurrent ascites secondary to cancer |
| Semi-permanent drain | – | Device: Rocket Indwelling Pleural CatheterPatient has a semi-permanent drain (Rocket Indwelling Pleural Catheter) placed for recurrent ascites secondary to cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See above
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 |
|---|---|---|
| Large Volume ParacentesisInsertion of a plastic tube into the abdomen and draining off ascitic fluid under local anaesthetic, removing the drain afterwards | Device | Large Volume Paracentesis |
| Rocket Indwelling Pleural CatheterA small plastic tube under the skin which is left in place so that the fluid can be drained if it builds up again | Device | Semi-permanent drain |
Primary outcome
Percentage presence and percentage completeness of the three QOL measures
Time frame: 3 months
8 secondary outcomes
Number of LVPs / Rocket IPC drainage episodes performed
Time frame: 3 months
Volumes of fluid removed at LVPs OR number of Rocket IPC bottles used at Rocket IPC drainage
Time frame: 3 months
Complications
Time frame: 3 months
The Edmonton Symptom Assessment System:Ascites Modification (ESAS:AM) DAILY
Time frame: 3 months
The EuroQol questionnaire (EQ-5D) as a generic QOL measure DAILY
Time frame: 3 months
The European Organization for the Research and Treatment of Cancer (EORTC) Core QOL Questionnaire (QLQ-C30) WEEKLY
Time frame: 3 months
Anti-cancer treatment received by the patient
Time frame: 3 months
Diuretics received by the patient
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Background: PubMed 23558342Day R, Mitchell T, Keen A, Perkins P. The experiences of patients with ascites secondary to cancer: a qualitative study. Palliat Med. 2013 Sep;27(8):739-46. doi: 10.1177/0269216313480400. Epub 2013 Apr 4.
- Background: PubMed 17505860Easson AM, Bezjak A, Ross S, Wright JG. The ability of existing questionnaires to measure symptom change after paracentesis for symptomatic ascites. Ann Surg Oncol. 2007 Aug;14(8):2348-57. doi: 10.1245/s10434-007-9370-3. Epub 2007 May 16.
- Individual participant dataSharing planned: No. Available on request
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ascites, Malignant, run by Gloucestershire Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Paul Perkins, MB BCh (+441242230199, paul.perkins@suerydercare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage presence and percentage completeness of the three QOL measures (time frame: 3 months). 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 NCT03550690, which also lists 2 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 11 Jun 2018.