EUS-Guided Drainage of Refractory Malignant Ascites

NCT ID: NCT03550560

Last Updated: 2018-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-09-01

Brief Summary

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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

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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.

Conditions

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Malignant Ascites

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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EUS-Guided drainage

Cancer patients in terminal phase with refractory malignant ascites

EUS-Guided drainage

Intervention Type PROCEDURE

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

Interventions

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EUS-Guided drainage

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Delos Clinical

OTHER

Sponsor Role collaborator

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rafael Romero Castro, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Central Contacts

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Secretaría Delos Clinical

Role: CONTACT

+34 954 001 079

Carlos García Perez

Role: CONTACT

+34 600 162 458

Other Identifiers

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JBO-ECO-2017-01

Identifier Type: -

Identifier Source: org_study_id

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