EUS-Guided Drainage of Refractory Malignant Ascites
Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cancer patients in terminal phase with refractory malignant ascites older 18 years of age
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
EUS-Guided drainage
Cancer patients in terminal phase with refractory malignant ascites
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Drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At 1 week.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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.
|
At 1 week.
|
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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.
|
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.
|
From baseline at 1 week.
|
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Change in Dyspnea by The modified Medical Research Council (mMRC) Scale.
Time Frame: From baseline at 1 week.
|
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: 0. Not troubled by breathlessness except on strenuous exercise.
According to the patient's response, dyspnea is classified as: 0. None, 1. Mild, 2. Moderate, 3. Severe and 4. Very severe. |
From baseline at 1 week.
|
|
Change in abdominal pain by The Visual Analogue Scale (VAS).
Time Frame: From baseline at 1 week.
|
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.
|
From baseline at 1 week.
|
|
Change in abdominal circumference.
Time Frame: From baseline at 1 week.
|
Circumference in centimeters.
|
From baseline at 1 week.
|
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Change in weight.
Time Frame: Form baseline at 1 week.
|
Weight in kilograms.
|
Form baseline at 1 week.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rafael Romero Castro, Dr., Hospital Universitario Virgen Macarena
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JBO-ECO-2017-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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