EUS-Guided Drainage of Refractory Malignant Ascites
Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses
1 other identifier
observational
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
June 8, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedJune 8, 2018
June 1, 2018
1 year
March 15, 2018
June 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
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)
From baseline at 1 week.
Change in Dyspnea by The modified Medical Research Council (mMRC) Scale.
From baseline at 1 week.
Change in abdominal pain by The Visual Analogue Scale (VAS).
From baseline at 1 week.
Change in abdominal circumference.
From baseline at 1 week.
- +1 more secondary outcomes
Study Arms (1)
EUS-Guided drainage
Cancer patients in terminal phase with refractory malignant ascites
Interventions
Drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses.
Eligibility Criteria
Cancer patients in terminal phase with refractory malignant ascites
You may qualify if:
- Cancer patients in terminal phase with refractory malignant ascites older 18 years of age
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Universitario Virgen Macarenalead
- Delos Clinicalcollaborator
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Romero Castro, Dr.
Hospital Universitario Virgen Macarena
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2018
First Posted
June 8, 2018
Study Start
September 1, 2018
Primary Completion
September 1, 2019
Study Completion
September 1, 2019
Last Updated
June 8, 2018
Record last verified: 2018-06