EUS-Guided Drainage of Refractory Malignant Ascites

Malignant Ascites Clinical Trial

Official title:

Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03550560
• Other study ID #: JBO-ECO-2017-01
• Status: Not yet recruiting
• Start date: September 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: June 2018
• Source: Hospital Universitario Virgen Macarena
• Contact: Secretaría Delos Clinical
• Phone: +34 954 001 079
• Email: secretaria[@]delosclinical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ascites
• Malignant Ascites

Intervention

Procedure:
• EUS-Guided drainage
Drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Virgen Macarena	Delos Clinical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	At 1 week.
Secondary	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.	From baseline at 1 week.
Secondary	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: 0. 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.	From baseline at 1 week.
Secondary	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.	From baseline at 1 week.
Secondary	Change in abdominal circumference.	Circumference in centimeters.	From baseline at 1 week.
Secondary	Change in weight.	Weight in kilograms.	Form baseline at 1 week.