Malignant AscitesNCT03550560
EUS-Guided Drainage of Refractory Malignant Ascites
An observational study of Malignant Ascites, run by Hospital Universitario Virgen Macarena.
Trial summary
This study evaluates the efficacy and safety of drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses. Patients with cancer older than 18 years with a life expectancy of less than 6 months who undergo EUS-Guided will be included in the study. 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?
- EUS-Guided drainage
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 1 Sep 2019
- How long will I take part?
- 1 Year
- 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: Cancer patients in terminal phase with refractory malignant ascites
Who may be able to join
- Cancer patients in terminal phase with refractory malignant ascites older 18 years of age
Who cannot join
- Patients under 18 years of age
- Patients with a life expectancy greater than 6 months
- Patients who are receiving cancer treatment for curative purposes or who suffer from a psychiatric disorder that prevents them from understanding and accepting the procedure
- Patients who do not accept to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses
This study evaluates the efficacy and safety of drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses. Patients with cancer older than 18 years with a life expectancy of less than 6 months who undergo EUS-Guided will be included in the study.
Read the detailed description
Malignant ascites is described as the presence of fluid in the abdominal cavity due to the presence of tumors. Its appearance is a predictor of worse prognosis in the evolution of malignant neoplasm and reduces the quality of life of patients.
The use of prostheses with drainage to the gastric cavity has shown good clinical results as the reduction of paracentesis evacuation needs. This achieves the reduction of hospital admissions and the improvement of the quality of life of the patient.
In order to verify the usefulness of this drainage technique, a prospective observational study has been designed. Patients with cancer over 18 years of age will be included, with a life expectancy of less than 6 months and who have undergone drainage of refractory malignant ascites through the implantation of plastic prostheses.
Participants receive the intervention in the same manner and intensity if they are not enrolled in the study.
- Conditions
- Malignant Ascites
- Being tested
- EUS-Guided drainage
- Keywords
- Endoscopic Ultrasound-Guided, EUS-Guided, Transgastric plastic prostheses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-Guided drainageProcedure or surgery
Drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses.
| Study group | Role | What they receive |
|---|---|---|
| EUS-Guided drainage | Cancer patients in terminal phase with refractory malignant ascites Receives: Procedure: EUS-Guided drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of new evacuation paracentesis after the procedure.
Paracentesis is an invasive technique that, by means of an abdominal percutaneous puncture, allows us to evacuate fluid from the peritoneal cavity. However, it only provides temporary improvement because the rapid recurrence of fluid usually occurs in about 72 hours.
Measured: At 1 week.
Secondary outcomes (6)
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
CTCAE is widely accepted throughout the oncology community as the standard classification and severity grading scale for adverse events in cancer therapy clinical trials and other oncology settings.
Measured: At 1 week.
Change in quality of life by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-palliative care (EORTC QLQ-C15-PAL)
EORTC QLQ-C15-PAL is a questionnaire developed to assess the quality of life of palliative cancer care patients. It comprises 15 questions including two functional scales (physical function and emotional function), two multi-item symptom scales (fatigue and pain), and five single-item symptom scales (nausea and vomiting, dyspnea, insomnia, appetite loss, and constipation). Response options to these 14 items use a four-point Likert scale: 1 (not at all), 2 (a little), 3 (quite a bit), and 4 (very much). An additional item, global health/quality-of-life scale, uses a seven point numerical scale from 1 (very poor) to 7 (excellent). Higher scores for the functional scale and global health/quality-of-life scale indicate better quality of life. However, higher symptom scales indicate lower quality of life.
Measured: From baseline at 1 week.
Change in Dyspnea by The modified Medical Research Council (mMRC) Scale.
The mMRC scale is used to establish the severity of dyspnea attributable to the respiratory disease.
The mMRC is a self-administered questionnaire where the patient must choose one among five statements based on the perception of the patient in daily activities:
- Not troubled by breathlessness except on strenuous exercise.
- Short of breath when hurrying or walking up a slight hill.
- Walks slower than peers on level ground due to dyspnea, or must to stop for breath when walking at own pace.
- Stops for breath after walking about 100m or after a few minutes on level ground.
- Too breathless to leave the house, or breathless when dressing or undressing.
According to the patient's response, dyspnea is classified as: 0. None, 1. Mild, 2. Moderate, 3. Severe and 4. Very severe.
Measured: From baseline at 1 week.
Change in abdominal pain by The Visual Analogue Scale (VAS).
VAS is a measurement instrument that permite to measure pain. The VAS used is a straight horizontal line of 100 mm. The ends are defined as the extreme limits of the parameter to be measured orientated from the left (worst) to the right (best). Using a ruler, the score is determined by measuring the distance (mm) between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: From baseline at 1 week.
Change in abdominal circumference.
Circumference in centimeters.
Measured: From baseline at 1 week.
Change in weight.
Weight in kilograms.
Measured: Form baseline at 1 week.
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 start1 Sep 2018 (estimated)
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Collaborators
- Delos Clinical
- Responsible party
- Sponsor
- Investigators
- Rafael Romero Castro, Dr., Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03550560
- Sponsor's protocol ID
- JBO-ECO-2017-01
- Status last verified
- Jun 2018
- First submitted
- 15 Mar 2018
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses
- ClinicalTrials.gov ID
- NCT03550560
- Acronym / sponsor ID
- JBO-ECO-2017-01
- Conditions
- Malignant Ascites
- Keywords
- Endoscopic Ultrasound-Guided, EUS-Guided, Transgastric plastic prostheses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Collaborators
- Delos Clinical
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 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.
This study evaluates the efficacy and safety of drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses. Patients with cancer older than 18 years with a life expectancy of less than 6 months who undergo EUS-Guided will be included in the study.
Detailed description
Malignant ascites is described as the presence of fluid in the abdominal cavity due to the presence of tumors. Its appearance is a predictor of worse prognosis in the evolution of malignant neoplasm and reduces the quality of life of patients.
The use of prostheses with drainage to the gastric cavity has shown good clinical results as the reduction of paracentesis evacuation needs. This achieves the reduction of hospital admissions and the improvement of the quality of life of the patient.
In order to verify the usefulness of this drainage technique, a prospective observational study has been designed. Patients with cancer over 18 years of age will be included, with a life expectancy of less than 6 months and who have undergone drainage of refractory malignant ascites through the implantation of plastic prostheses.
Participants receive the intervention in the same manner and intensity if they are not enrolled in the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-Guided drainage | – | Procedure: EUS-Guided drainageCancer patients in terminal phase with refractory malignant ascites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients in terminal phase with refractory malignant ascites
Key inclusion criteria (1 listed)
- Cancer patients in terminal phase with refractory malignant ascites older 18 years of age
Key exclusion criteria (4 listed)
- Patients under 18 years of age
- Patients with a life expectancy greater than 6 months
- Patients who are receiving cancer treatment for curative purposes or who suffer from a psychiatric disorder that prevents them from understanding and accepting the procedure
- Patients who do not accept to participate in the study.
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 |
|---|---|---|
| EUS-Guided drainageDrainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses. | Procedure or surgery | EUS-Guided drainage |
Primary outcome
Number of new evacuation paracentesis after the procedure.
Time frame: At 1 week.
Paracentesis is an invasive technique that, by means of an abdominal percutaneous puncture, allows us to evacuate fluid from the peritoneal cavity. However, it only provides temporary improvement because the rapid recurrence of fluid usually occurs in about 72 hours.
6 secondary outcomes
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: At 1 week.
Change in quality of life by The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-palliative care (EORTC QLQ-C15-PAL)
Time frame: From baseline at 1 week.
Change in Dyspnea by The modified Medical Research Council (mMRC) Scale.
Time frame: From baseline at 1 week.
Change in abdominal pain by The Visual Analogue Scale (VAS).
Time frame: From baseline at 1 week.
Change in abdominal circumference.
Time frame: From baseline at 1 week.
Change in weight.
Time frame: Form baseline at 1 week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
Anti-PD-1 in Combination With Systemic Chemotherapy With Nab-paclitaxel Intraperitoneal Infusion for Untreated Advanced Gastric Cancer With Malignant Ascites
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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.
Rafael Romero Castro, Dr. principal investigator
Hospital Universitario Virgen Macarena
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Ascites, run by Hospital Universitario Virgen Macarena.
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 1 inclusion and 4 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 8 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 Secretaría Delos Clinical (+34 954 001 079, secretaria@delosclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of new evacuation paracentesis after the procedure. (time frame: At 1 week.). 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 8 Jun 2018.