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EUS-Guided Drainage of Refractory Malignant Ascites

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ClinicalTrials.gov Identifier: NCT03550560
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Delos Clinical
Information provided by (Responsible Party):
Hospital Universitario Virgen Macarena

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.

Condition or disease Intervention/treatment
Malignant Ascites Procedure: EUS-Guided drainage

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Drainage of Refractory Malignant Ascites by Endoscopic Ultrasound-guided (EUS-Guided) Implantation of Plastic Prostheses
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Group/Cohort Intervention/treatment
EUS-Guided drainage
Cancer patients in terminal phase with refractory malignant ascites
Procedure: EUS-Guided drainage
Drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

    1. Short of breath when hurrying or walking up a slight hill.
    2. Walks slower than peers on level ground due to dyspnea, or must to stop for breath when walking at own pace.
    3. Stops for breath after walking about 100m or after a few minutes on level ground.
    4. 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.


  4. 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.

  5. Change in abdominal circumference. [ Time Frame: From baseline at 1 week. ]
    Circumference in centimeters.

  6. Change in weight. [ Time Frame: Form baseline at 1 week. ]
    Weight in kilograms.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients in terminal phase with refractory malignant ascites
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550560


Contacts
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Contact: Secretaría Delos Clinical +34 954 001 079 secretaria@delosclinical.com
Contact: Carlos García Perez +34 600 162 458 administracion.eecc.hvm.sspa@juntadeandalucia.es

Sponsors and Collaborators
Hospital Universitario Virgen Macarena
Delos Clinical
Investigators
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Principal Investigator: Rafael Romero Castro, Dr. Hospital Universitario Virgen Macarena

Additional Information:

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Responsible Party: Hospital Universitario Virgen Macarena
ClinicalTrials.gov Identifier: NCT03550560     History of Changes
Other Study ID Numbers: JBO-ECO-2017-01
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hospital Universitario Virgen Macarena:
Endoscopic Ultrasound-Guided
EUS-Guided
Transgastric plastic prostheses

Additional relevant MeSH terms:
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Ascites
Pathologic Processes