Clinical trial NCT03550560: EUS-Guided Drainage of Refractory Malignant Ascites
Official title: Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Ascites
Keywords: Endoscopic Ultrasound-Guided
EUS-Guided
Transgastric plastic prostheses
Lead sponsor: Hospital Universitario Virgen Macarena
Sponsor class: OTHER
Collaborators: name: Delos Clinical
First posted: 2018-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients in terminal phase with refractory malignant ascites

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of new evacuation paracentesis after the procedure.
timeFrame: At 1 week.
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
timeFrame: At 1 week.
measure: 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)
timeFrame: From baseline at 1 week.
measure: Change in Dyspnea by The modified Medical Research Council (mMRC) Scale.
timeFrame: From baseline at 1 week.
measure: Change in abdominal pain by The Visual Analogue Scale (VAS).
timeFrame: From baseline at 1 week.
measure: Change in abdominal circumference.
timeFrame: From baseline at 1 week.
measure: Change in weight.
timeFrame: Form baseline at 1 week.
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Rafael Romero Castro, Dr.
role: PRINCIPAL_INVESTIGATOR
References: